FDA Adverse Event
Injury
Summary report: N
NUGRIP SZ. 20M
MDR report key: 2459384
·
Received February 14, 2012
Report
- Report Number
- 1651501-2012-00012
- Event Type
- Injury
- Date Received
- February 14, 2012
- Report Date
- February 14, 2012
- Manufacturer
- ASCENSION ORTHOPEDICS
- Product Code
- KYI
- PMA / PMN Number
- K112278
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATE THAT THE CARPOMETACARPAL JOINT OF THE THUMB, WHERE THE DEVICE HAD BEEN IMPLANTED WAS PAINFUL AND LOOSE. THE PT IS A LARGE MAN WITH A SMALL TRAPEZIUM. THE SURGEON REPORTED THAT THE DEVICE NEVER SAT WELL INTO THE CARPAL BONE. THE DEVICE WAS REMOVED AND A STANDARD PROCEDURE LIGAMENT RECONSTRUCTION WAS DONE. THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL. IT HAD A NORMAL APPEARANCE ON EXPLANTATION. THE EXACT PRODUCT CATALOGUE NUMBER AHS NOT BEEN PROVIDED. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUGRIP SZ. 20M | NUGRIP | KYI | ASCENSION ORTHOPEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |