FDA Adverse Event
Other
Summary report: N
NEUROFLEX
MDR report key: 1278336
·
Received December 23, 2008
Report
- Report Number
- 2249852-2008-00003
- Event Type
- Other
- Date Received
- December 23, 2008
- Date of Event
- September 2, 2008
- Report Date
- December 15, 2008
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- JXI
- PMA / PMN Number
- K012814
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
SURGEON NOTICED A TRANSVERSE DISRUPTION NEAR THE PROXIMAL ATTACHMENT POINT OF A NERVE. SMALL PORTION OF CONDUIT WAS EXTRACTED, AND THE NERVE WAS REATTACHED TO THE REMAINING PRODUCT. MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES WERE PERFORMED BETWEEN INITIAL IMPLANT AND WHEN ISSUE WAS NOTED ON 9/2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROFLEX | COLLAGEN NERVE CONDUIT | JXI | COLLAGEN MATRIX, INC. | CNCF5025 | 0703182032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MULTIPLE IRRIGATION AND DEBRIDEMENT |