FDA Adverse Event
Injury
Summary report: N
GORE PRECLUDE DURA SUBSTITUTE
MDR report key: 3144245
·
Received May 24, 2013
Report
- Report Number
- 2017233-2013-00324
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- August 1, 1995
- Report Date
- May 13, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- 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 FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER REMAINS UNK. THE DEVICE WAS NOT RETURNED TO GORE, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED.
Description of Event or Problem · 1
IN AN ARTICLE TITLED, "POSTOPERATIVE INFECTION AFTER DURAPLASTY WITH EXPANDED POLYTETRAFLUOROETHYLENE SHEET" IT INDICATES 1 PT DEVELOPED AN INFECTION REQUIRING REINTERVENTION. THE INFECTION RESOLVED AFTER REMOVAL OF THE INFECTED BONE AND THE EPTFE MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230655 | GORE PRECLUDE DURA SUBSTITUTE | GXQ / DURA SUBSTITUTE | GXQ | W.L. GORE & ASSOCIATES, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |