VEGA IMPLANT Ø3.5 X 8MM
Received Jun 18, 2025 · Event occurred Sep 27, 2022
Report 3003267134-2025-00002 · MDR key 22284567
Device
Product problems
- Loss of Osseointegration
- Patient Device Interaction Problem
- Loss of Osseointegration
- Patient Device Interaction Problem
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
THE CLIENT SENDS THE FRACTURED IMPLANT WITH ITS PROSTHESIS.THE CLIENT IS REPEATEDLY ASKED TO SUBMIT THE QUALITY REPORT (A DOCUMENT CONTAINING ALL THE PATIENT INFORMATION AND INFORMATION ABOUT THE PRODUCT AND THE INCIDENT) WITHOUT RECEIVING A RESPONSE. THE CLIENT DOES NOT PROVIDE ANY BATCH AND REFERENCE DATA OF THE PRODUCT.
Additional Manufacturer Narrative
ALTHOUGH THE INFORMATION RECEIVED IS LIMITED, IT CAN BE CONCLUDED THAT THE IMPLANT HAS BEEN WORKING UNDER UNFAVORABLE CONDITIONS SINCE THE PROSTHETIC HEIGHT IS WITHIN THE MAXIMUM RECOMMENDED LIMIT (IT SHOULD NOT EXCEED THE LENGTH OF THE IMPLANT) AND THE PROSTHETIC DIAMETER IS TWO AND A HALF TIMES GREATER THAN THE IMPLANT DIAMETER.
Remedial action
- Notification