FDA Adverse Event
Injury
Summary report: N
APTUS
MDR report key: 22994306
·
Received September 8, 2025
Report
- Report Number
- 3003236702-2025-00002
- Event Type
- Injury
- Date Received
- September 8, 2025
- Date of Event
- June 11, 2025
- Report Date
- September 8, 2025
- Manufacturer
- MEDARTIS AG
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IF MORE SUFFICIENT INFORMATION IS AVAILABLE, MEDARTIS AG WILL SUBMIT A FOLLOW-UP REPORT.
Description of Event or Problem · 0
PATIENT WAS INJURED WHEN A MEDARTIS 2.5 TRILOCK FUSION TITANIUM PLATE, WHICH HAD BEEN IMPLANTED IN WRIST, SNAPPED/FRACTURED. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT FOR THE INJURIES SUSTAINED DUE TO THE FAILURE OF THE PRODUCT. A SECOND SURGERY TO REMOVE THE FAILED DEVICE IS SCHEDULED FOR NOVEMBER OF THIS YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2441075 | APTUS | APTUS | HRS | MEDARTIS AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H |