OPRA IMPLANT SYSTEM
Report
- Report Number
- 3011386779-2025-00238
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- June 18, 2025
- Report Date
- August 20, 2025
- Manufacturer
- INTEGRUM
- Product Code
- PJY
- PMA / PMN Number
- P190009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FIXTURE REMOVAL SURGERY DUE TO A FRACTURED FIXTURE. ONLY HALF OF THE FIXTURE WAS ABLE TO BE REMOVED ON (B) (6). THE REMAINING PART IS PLANNED TO BE REMOVED LATER IN (B)(6) THE PROCEDURE TOOK PLACE IN FRANCE ON (B)(6) 2025. THIS IS A PLATFORM F FIXTURE, AN OLDER DESIGN THAN IN THE PMA P190009. THIS IS REPORTED BECAUSE THE DESIGN IS VERY SIMILAR TO THE PMA APPROVED DESIGN.
FIXTURE REMOVAL SURGERY DUE TO A FRACTURED FIXTURE. HALF OF THE FIXTURE WAS ABLE TO BE REMOVED ON (B)(6) 2025. THE REMAINING PART WAS REMOVED ON (B)(6) 2025. THE PROCEDURES TOOK PLACE IN FRANCE ON (B)(6) 2025 AND (B)(6), 2025. THIS IS A PLATFORM F FIXTURE, AN OLDER DESIGN THAN IN THE PMA P190009. THIS IS REPORTED BECAUSE THE DESIGN IS VERY SIMILAR TO THE PMA APPROVED DESIGN.
FIXTURE REMOVAL SURGERY DUE TO A FRACTURED FIXTURE. ONLY HALF OF THE FIXTURE WAS ABLE TO BE REMOVED ON (B)(6). THE REMAINING PART IS PLANNED TO BE REMOVED LATER IN (B)(6). THE PROCEDURE TOOK PLACE IN FRANCE ON (B)(6) 2025.
FIXTURE REMOVAL SURGERY DUE TO A FRACTURED FIXTURE. HALF OF THE FIXTURE WAS ABLE TO BE REMOVED ON (B)(6) 2025. THE REMAINING PART WAS REMOVED ON (B)(6) 2025. THE PROCEDURES TOOK PLACE IN FRANCE ON (B)(6) AND (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1214977 | OPRA IMPLANT SYSTEM | FIXTURE | PJY | INTEGRUM | 1340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |