FDA Adverse Event
Injury
Summary report: N
AXIS
MDR report key: 16482045
·
Received March 3, 2023
Report
- Report Number
- 3007289093-2022-00018
- Event Type
- Injury
- Date Received
- March 3, 2023
- Date of Event
- December 14, 2022
- Report Date
- February 8, 2023
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- HWC
- PMA / PMN Number
- K211261
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THREE AXIS BEAMS WERE REMOVED. THE BEAMS WERE PINCHING INTO ADJACENT JOINTS CAUSING PAIN. SCREWS IN THE HEEL WERE PROMINENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2012196 | AXIS | BONE SCREW | HWC | EXTREMITY MEDICAL, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |