Please Complete This Form Entirely and Return It Per Below

Complaint Report

Please complete this form entirely and return it per below.

1. Contact Information: / Incident #: / ____
ð ** If event involves an IMPLANT, complete SECTIONS 1 – 4.1 ** ï / Replacement Order #: / ____
Form Completed by: / ______/ Date: / ______
Complainant Name: / ______/ Phone: / ______/ Email: / ______
Tr. Mgr or Distributor: / ______/ Phone: / ______
Account Details: / Account Name: / ______/ Acct #: / ______
Address: / ______/ Doctor: / ______
City, State, Zip, Country / ______/ Patient: / ______
(Do not fill in Patient Name in Europe)
Phone: / ______/ Fax: / ______/ Email: / ______
Customer Type: Clinician Lab Distributor
2. Product Information: Separate forms should be used for individual complaints. If more than one device is associated with a single event being reported, multiple Item #s may be used. A device label can be attached as an alternative.
Item # / Qty. / Lot / Serial Number / Order Number
(if lot # is not known) / Requested Replacement Item #
(if different)
Product Family Affected: Implant Restorative Components Site Preparation & Instruments Regenerative
Is the product available for evaluation? / Yes. Items HAVE been decontaminated & will be returned.
No. Items are not available. Why? ______
Note: When sending product for evaluation use standard autoclave pouch and attach this form.
Are radiographs available? / Yes. No. In Europe, the patient’s name must be removed from the x-ray
3. Event Details:
Event Date: / ______/ Biomet 3i Notification Date: / ______
1. Is there an alleged failure of the device to perform as intended? Yes No
2. Is this event directly related to a previously reported event? Yes No
3. Provide a brief description of the reported problem including the background (i.e. procedure being performed):
4. Tooth location? Maxilla (Labial View)
Not Applicable
If applicable, mark the tooth location:
Mandible (Labial View)
5. Age: / Unknown
/ 6. Gender: Female Male
Complete the appropriate product(s) section. If there is patient involvement; section 5 must also be completed.
4. Product Family Section: Fill out the section(s) that best describes the product(s) that are related to this event.
4.1 Implant Product Family:
1. What associated product(s) and settings were used that may have contributed to the reported event (e.g. driver, tools, torque value, etc.)? ______
2. Are the associated product(s) and/or prosthesis available for evaluation? / Yes No
3. Was the implant: Restored Not Yet Restored / 4. Placement Date: _____ / 5. Removal Date: _____
6. Event / Problem Description (check all that apply):
Non-integration (NI) Loss of Integration (LI) Device Fracture Accident or Trauma Fit* Infection
Handling-Loss of Sterility Malfunction Mislabeled* Biomechanical Overload/Stress Other*
*Please describe: ______
7. Remedial Action(s) Taken: Yes No
If Yes, what additional treatment was taken by the clinician in response to this incident? Is additional remedial treatment planned? Please describe: ______
8. Did the patient present any relative patient profile? (Check all that apply):
Smoker Diabetes Osteoporosis Other ______
9. Describe the density of the bone:
High Density (Type I) Moderate Density (Type II) Low Density (Type III or IV)
10. Was the implant placed in a previously or simultaneously grafted site? Yes No:
Autogenous Alloplast Allograft Hybrid Xenograft Other ______
11. Was the implant placed into an immediate extraction site? Yes No
12. Implant placement protocol: Single Stage (transgingival) Two Stage (submerged)
13. Was the implant loaded (provisional or final) prior to failure? Yes No:
Immediate (within 48 hours) Early (within 8 weeks) Traditional – Delayed (3-4 months mandible, 4-6 months maxilla)
14. Submit this form with the following items if applicable / available: (Indicate which items are being submitted)
Photographs Radiographs CT Scan Screen Shot(s) Prosthesis / Instrumentation
15. Replacement product requested? Yes No
4.2 Restorative Products: (Examples: abutments, screws, etc.)
If the complaint pertains to a restorative component, please answer the following:
Note: For complaints related to Patient Specific Products use BellaTek™ Complaint Report Form – M05.01.01.05
1. What related product(s) and settings were used that may have contributed to the reported event (e.g. driver, tools, torque value, etc.)? ______
2. Is the associated product(s) available for evaluation? Yes No
3. Event / Problem Description (check all that apply):
Fracture Malfunction Fit Appearance Size Instructions Not Followed Other
4.3 Site Preparation and Instrumentation Products: (Examples: drills, bone profilers, etc.)
If the complaint pertains to a site preparation and instrumentation product, please answer the following:
1. What related product(s) were used that may have contributed to the reported event (e.g. driver, tools, torque value, etc.)?
______
2. Is the associated product(s) available for evaluation? Yes No
3. Event / Problem Description (check all that apply):
Malfunction Fracture Appearance Other ______
4.4 Regenerative Products: (Examples: Bone grafting materials and related.)
If the complaint pertains to a regenerative product, please answer the following:
1. What related product or technique was used that may have contributed to the reported event (e.g. preparation, tools, etc.)? ______
2. Is the associated product(s) available for evaluation? Yes No
3. Event / Problem Description (check all that apply):
Malfunction Fracture Appearance Other ______
5. Event Questions – MUST BE COMPLETED for all complaints except:
NI/LI (non-integration / loss of integration) or complaints that did not involve a patient.
Did the complaint product have patient interaction: Yes No If Yes, complete section below.
As it relates to the event:
1. Yes / No / Unk / Was there a death?
2. Yes / No / Unk / Did the event cause or contribute to a serious deterioration in the state of health or a serious injury* to patient, user or other person? If yes, explain injury ______
3. Yes / No / Unk / Did a delay in the surgical procedure over 30 minutes contribute to an injury or serious deterioration in the patient’s health? If yes, what was the duration of the delay? ____
4. Yes / No / Unk / Did an unanticipated surgical complication occur? If yes, please explain ______
5. Yes / No / Unk / Were there any contributing conditions related to the event? (Ex: trauma, illness, previous surgery, related non-compliance.) If yes, explain variation or circumstance. ______
6. Yes / No / Unk / Was there any variance from the expected surgical technique? If yes, explain technique and variation or circumstance. ______
7. Yes / No / Unk / Did the patient retain a foreign body?
*Serious Injury means that the event was (1) life threatening (2) resulted in permanent impairment of a body function or structure, or (3) necessitated medical/surgical intervention to preclude permanent impairment of a body function or structure.
6. Additional Information:
When are you available to discuss with the Complaint Handling Representative? (If Needed)
List time(s) and Date(s): ______
Review: The information above is an accurate representation of the complaint being reported:
Complainant’s or Reporter’s Signature: ______Date: ______
7. Final Review: (to be completed by Biomet 3i Complaints Handling)
Reviewed by: ______Date: ______
Follow up information: (If Needed) ______

Form must be filled out completely.

Options for submitting the form to the applicable Complaint Handling Team:

1. Fill out the form out as a Word document, save it, attach it to an email and send to the correct Biomet Complaint Handling Location.

2. While using Word 2007, fill out the form and click on the office button “” (top left corner when Word is open). Click the Send option, and then click the email option. A new email will open. Send the form to the correct Biomet Complaint Handling Location.

3. Print the form and fill out required information. Fax or email the form to the correct Biomet Complaint Handling Location.

Product returned must include the Complaint Number or a copy of the complaint form. Provide complaint product to your local representative or send returned product to:

US: International (APAC, Non European & Biomax): Europe:

Email: Email: Email:

Address: Address: Address:

Biomet 3i Biomet 3i WTC Almeda Park

Complaints Handling Complaints Handling Pl. de la Pau s/n, Ed.1 Pl. 1a 08940

4555 Riverside Dr. 4555 Riverside Dr. Cornella de Llobreagat, Barcelona, Spain

Palm Beach Gardens, FL 33410 Palm Beach Gardens, FL 33410 USA Spain:

Phone: 1.800.443.8166 Phone: 561.776.6918 Phone: 900 800 303 ó +34 93 470 59 50

Fax: 561.514.6316 Fax: 561.383.3310 Fax: +34 93 445 81 36

France: Germany: Austria:

Biomet 3i Biomet 3i Biomet 3i

7-9 Rue Paul Vaillant Couturier Lorenzstrasse 29 Breitwies 1

92300 LeVallois Perret 76133 Karlsruhe 5303 Thalgau

Phone: +33 (0) 141.05.43.43 Phone: +49 (0) 800 101 6420 Phone: +43 (0) 800 07 0017

Fax: +33 (0) 141.05.43.40 Fax: +49 (0) 800 313 1111 Fax: +43 (0) 800 00 700 18

Switzerland: Netherlands: Belgium:

Biomet 3i Biomet 3i Biomet 3i

Riedstrasse 6 TAV: Customer Service TAV: Customer Service

8953 Zurich Toermalijnring 600 Prins Boudewijnlaan 24C

Phone: +41 (0) 800 246 638 3301 LC Dordrecht 2550 Kontich

Fax: +41 (0) 800 246 639 Nederland Belgium

Phone: +31 786292800 Phone: +32 80050311

Fax: +31 786292801 Fax: +32 80050312

UK and Ireland: Nordic:

Biomet 3i UK Biomet 3i Nordic

1 Bell Street Box 306

Maidenhead SE-201 23 Malmo

Berkshire, UK SL6 1BU Sweden

Phone: + 44 (0) 8006521233 Phone: +46 200 12 55 09

Fax: + 44 (0) 800 840 6814 Fax: +46 200 12 55 06

Swedish:

Phone: +46 40 17 60 90 Fax: +46 40 17 60 99

Ireland: Danish:

Phone: +353 1800 552752 Phone: +45 33 12 70 08 Fax: +45 33 12 70 03

Fax: +353 1800 656608 Norwegian:

Phone: +47 222 012 70 Fax: +47 228 397 40

ROW:

Canada: Phone: 514-956-9843 Fax: 514-956-9844

Australia: Phone: +61 2 9855 4444 Fax: +61 2 9888 9900

Mexico: Phone: + 52 55 2282 0120 Fax: + 52 55 2282 0120 ext 20

DISCLAIMER: This information is being gathered to assist in complying with regulatory reporting requirements in the US, Europe, Canada, Australia & Brazil [and, from time to time, in various other jurisdictions.] The information contained on this form does not constitute an admission that any person, entity or product referenced herein or in relating documentation may have caused or contributed to any issue arising from, or the, event.

M05.01.01.01 Rev 16 Page 1 of 4

Complaint Report

M05.01.01.01 Rev 16 Page 1 of 4