FDA Adverse Event
Malfunction
Summary report: N
X-RING FIXATOR
MDR report key: 23417106
·
Received October 29, 2025
Report
- Report Number
- 3007289093-2025-00011
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- September 4, 2025
- Report Date
- October 29, 2025
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- KTT
- UDI-DI
- 00842078135501
- PMA / PMN Number
- K251128
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT GOT THE TIBIAL HALF PIN CAUGHT ON HIS WHEELCHAIR AND SHEARED IT OFF AT THE CORTEX PIN INTERFACE. THE HALF PIN WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2557709 | X-RING FIXATOR | EXTERNAL FIXATION SYSTEM | KTT | EXTREMITY MEDICAL, LLC. | 2309-13 | 00842078135501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |