FDA Adverse Event
Malfunction
Summary report: N
OPERA IMPLANT SYSTEM
MDR report key: 24386107
·
Received February 19, 2026
Report
- Report Number
- 3011386779-2025-00261
- Event Type
- Malfunction
- Date Received
- February 19, 2026
- Date of Event
- December 23, 2025
- Report Date
- March 12, 2026
- Manufacturer
- INTEGRUM AB
- Product Code
- PJY
- UDI-DI
- 07340152100634
- PMA / PMN Number
- P190009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
2026-01-22: INTEGRUM WAS INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE UNIT HAS NOT YET BEEN RECEIVED, HENCE NO TECHNICAL INVESTIGATION PERFORMED.
Description of Event or Problem · 0
2026-01-22: INTEGRUM WAS INFORMED THAT AXOR II UNIT I9527 HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE UNIT HAS NOT YET BEEN RECEIVED, HENCE NO TECHNICAL INVESTIGATION PERFORMED. 2026-03-07: TECHNICAL INVESTIGATION OF UNIT I9527 PERFORMED. DURING INVESTIGATION, THE FAILURE COULD NOT BE REPLICATED, THE UNIT PASSED ALL FUNCTIONAL TESTS. DURING SERVICE, THE UNIT WAS CLEANED, THE BENDING PUNCH REPLACED AND THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96697 | OPERA IMPLANT SYSTEM | AXOR II | PJY | INTEGRUM AB | 1288 | 58775 | 07340152100634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |