FDA Adverse Event
Other
Summary report: N
NEURAGEN NERVE GUIDE 4MM ID X 3CM LENGTH
MDR report key: 1576598
·
Received January 11, 2010
Report
- Report Number
- 1121308-2010-00001
- Event Type
- Other
- Date Received
- January 11, 2010
- Date of Event
- December 21, 2009
- Report Date
- January 11, 2010
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- JXI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE PRODUCT THAT HAD A LOT EXPIRATION DATE OF 07/2009 WAS IMPLANTED DURING A SURGICAL PROCEDURE THAT WAS DONE ON (B)(6) 2009. THE SURGERY ON THE RIGHT WRIST INVOLVED A REPAIR OF THE DIGITAL NERVE. THERE HAS BEEN NO ADVERSE OUTCOME FOR THE PATIENT REPORTED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURAGEN NERVE GUIDE 4MM ID X 3CM LENGTH | NEURAGEN | JXI | INTEGRA LIFESCIENCES CORP. | 1072143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | COMPRESSION PLATE| SCREWS |