InjuryDZE
NEOSS
Received Jun 16, 2026 · Event occurred Jan 9, 2026
Report 3017399129-2026-00079 · MDR key 25516129
Device
Generic name
Dental Implants
Manufacturer
Neoss AbProduct problems
- Fracture
Patient
NA · Unknown
- Failure of Implant
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DENTAL IMPLANT HAD FRACTURED. THEREFORE, BECAUSE OF A RISK OF SERIOUS INJURY, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RECEIVED BACK FROM CUSTOMER. PRODUCT RETURN IS REQUESTED, AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.
Description of Event or Problem
IMPLANT FRACTURED.