Observation Form Guidance Notes
The Observation Form should be used to report any event in which:
- A CERAMENT™ device is suspected to have contributed to the event
- A CERAMENT™ device has failed to perform in accordance with its intended purpose, when used in accordance with the Instructions for Use
- The event led or might have led to the death of a patient, or user or of other person or to serious deterioration in the state of health of a patient, or user or of other persons
Observations can also be submitted in writing to BONESUPPORT by email at:.
For any other observations, such as queries or feedback about our products, please fill in the form on the ‘Contact us’ section of our website.
How do I fill in the observationform?
Please fill in both pages and send it to the address shown in the first section of the form – either by post or email
The observation information is the second section on the form.
‘Received by’ is the person to whom the complaint was reported to, and the ‘Notified date’ is the date on which they were told about the event
The customer information supplied should be the name and address of the person that the BONESUPPORT AB Quality & RegulatoryManagement (QRM) department can contact for more information if necessary, and report the findings of any investigation to. This may not always be the person who experienced or reported the complaint – for example, a surgeon might have reported the complaint, but it is the theatre manager of the hospital who will want to see the response from BONESUPPORT AB for their records.
The Observation Details are on the second page of the form
It is important that as much information as possible is provided in this section, to facilitate a thorough investigation into the complaint
When a complaint has resulted in death or is life threatening, note there is a time limit of 24 hoursto report it
Where there has been a product malfunction, damaged packaging, incorrect labelling or incomplete device, please return the product to BONESUPPORT AB for analysis if possible – this is very helpful in determining what has happened, and putting corrective measures in place
Items returned to BONESUPPORT AB that have been used in theatres and may be contaminated should be clearly marked up as unsterile, and securely bagged for your safety and the safety of those opening the mail at BONESUPPORT AB
If you cannot return the product, please take photos of it and send these to customer services at
Fill in question 17 if information about the complaintor the product/packaging/device is not available, for example if the hospital is not willing or able to disclose some of the information. It is important to include this, as it may be submitted to the relevant authorities to support the investigation carried out by the QRM Department
The patient data section is the last on the form, and it is helpful to have any information in this section that might have been related to the event
If possible, please supply X-rays/CT scans if relevant