FDA Adverse Event
Injury
Summary report: N
GORE PRECLUDE DURA SUBSTITUTE
MDR report key: 3144249
·
Received May 24, 2013
Report
- Report Number
- 2017233-2013-00337
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- August 1, 1995
- Report Date
- May 13, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- GXQ
- PMA / PMN Number
- K953969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LITERATURE CITATION: NAKAGAWA, S, ET AL. POSTOPERATIVE INFECTION AFTER DURAPLASTY WITH EXPANDED POLYTETRAFLUOROETHYLENE SHEET, NEUROL MED CHIR (TOKYO), 2003 MARCH; 43:120-124. A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED BECAUSE THE LOT#S REMAIN UNK, THE DEVICES WERE NOT RETURNED TO GORE, SO NO ENGINEERING INVESTIGATIONS COULD BE PERFORMED.
Description of Event or Problem · 1
IN AN ARTICLE TITLED, "POSTOPERATIVE INFECTION AFTER DURAPLASTY WITH EXPANDED POLYTETRAFLUOROETHYLENE SHEET" IT INDICATES 3 PTS DEVELOPED INFECTIONS REQUIRING REINTERVENTION. THESE INFECTIONS RESOLVED AFTER REMOVAL OF THE INFECTED BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230609 | GORE PRECLUDE DURA SUBSTITUTE | GXQ/DURA SUBSTITUTE | GXQ | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |