FDA Adverse Event
Injury
Summary report: N
NUGRIP CMC IMPLANT
MDR report key: 2092879
·
Received May 11, 2011
Report
- Report Number
- 1651501-2011-00041
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 11, 2011
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYI
- PMA / PMN Number
- K041451
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT. A REVISION SURGERY HAS NOT BEEN REPORTED BUT MAY BE AN OPTION. X-RAYS WERE PROVIDED FOR ANALYSIS. THE X-RAYS APPEAR TO SHOW CYSTS AND LOOSENING. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENT REPORT WILL BE SUBMITTED AS APPROPRIATE.
Description of Event or Problem · 1
REPORTED THAT THE NUGRIP IMPLANT WAS CAUSING ISSUES FOR A PATIENT AFTER BEING IMPLANTED. FROM THE INFORMATION COLLECTED TO DATE THE EVENT APPEARS TO HAVE SOME CYSTS AND SOME LOOSING IS EVIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUGRIP CMC IMPLANT | WRIST JOINT CARPAL TRAPEZIUM PROSTHESIS | KYI | ASCENSION ORTHOPEDICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |