FDA Adverse Event
Malfunction
Summary report: N
DURAMATRIX
MDR report key: 796416
·
Received December 8, 2006
Report
- Report Number
- 2249852-2006-00002
- Event Type
- Malfunction
- Date Received
- December 8, 2006
- Date of Event
- November 3, 2006
- Report Date
- December 6, 2006
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- GXQ
- PMA / PMN Number
- K040888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR'S INVESTIGATION, INCLUDING REVIEW OF COMPLETE DEVICE HISTORY RECORD AND PHYSICAL TESTING OF RESERVE PRODUCT FROM THE SAME LOT, INDICATES THAT ALL IN-PROCESS, FINISHED PRODUCT, AND RE-TESTING RESULTS FOR THIS LOT MET ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
A CSF LEAK WAS FOUND 1 WEEK POST-OP. PROCEDURE WAS IN THE POSTERIOR FOSSA. A 3X3 INCH PIECE WAS SUTURED WITH 1 MM SPACING. FIBRIN GLUE WAS USED OVER THE SUTURES. NO TEAR OR ISSUES NOTED DURING IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURAMATRIX | COLLAGEN DURA SUBSTITUTE MEMBRANE | GXQ | COLLAGEN MATRIX, INC. | CDSM33 | 0604103022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |