FDA Adverse Event
Injury
Summary report: N
NEURAGEN NERVE GUIDE
MDR report key: 1286634
·
Received January 9, 2009
Report
- Report Number
- 1121308-2008-00019
- Event Type
- Injury
- Date Received
- January 9, 2009
- Date of Event
- December 9, 2008
- Report Date
- January 8, 2009
- Manufacturer
- INTEGRA LIFESCIENCES
- Product Code
- JXI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE PATIENT REPORTS THAT FOLLOWING SURGERY FOR ULNAR NERVE ENTRAPMENT AT THE CUBITAL LEVEL, DURING WHICH 3 UNITS OF THE DEVICE WERE USED, HE HAS EXPERIENCED RESIDUAL SENSORY DEFICIT, LOSS OF NERVE FUNCTION, ATROPHY AND PAIN SYNDROME. TWO UNITS OF NEURAGEN NERVE GUIDE PNG720, LOT NUMBER 1070206 WERE ALSO USED DURING THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN NERVE GUIDE | NERVE CONDUIT/WRAP | JXI | INTEGRA LIFESCIENCES | 1070004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other | SEPRAFILM (GENZYME) IMPLANTED AT TIME OF SURGERY |