GORE SYNECOR Preperitoneal Biomaterial GKWR3030Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE SYNECOR PREPERITONEAL 30cmX30cmRectangle Biomaterial · Class 2 · Implant
All models of GORE SYNECOR Preperitoneal Biomaterial (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132653706), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN PERFORMED A ROBOTIC TAR ON (B)(6) 2023 (NOT A BRIDGING REPAIR). HE IMPLANTED A PIECE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL BETWEEN TISSUE PLANES AS WELL AS PLACING A DRAIN AND USING AN ABDOMINAL BINDER POST-OPERATIVELY. THIS PATIENT PRESENTED TO HIM IN CLINIC IN THE FOLLOWING MONTHS WITH A 2 CM SORE/PIMPLE THAT WOULD NOT GO AWAY. THIS WAS TREATED WITH ANTIBIOTICS AS WELL AS OPEN DRAINAGE AND YET THIS RED SORE/PIMPLE STILL WOULD NOT GO AWAY. ON (B)(6), 2023 THE SURGEON REEXPLORED THIS WOUND IN THE OR AND RESECTED INFECTED SYNECOR. THE FSA ATTENDED THE CASE AND TOOK A PHOTO OF THE PIECE OF EXPLANTED MESH WHICH HAD NOT INGROWN. THE PATIENT¿S RELEVANT MEDICAL HISTORY INCLUDES HYPERTENSION AND HAVING CEREBRAL PALSY. ON THE DATE OF REOPERATION THE PATIENT WAS A 60 YEAR OLD FEMALE AND WEIGHED 152 LBS. IT WAS STATED BY THE FSA THAT THIS INFECTION WAS NOT CONSIDERED A FISTULA, IT WAS NOT DUE TO DEHISCENCE OF A SURGICAL SITE OR TROCAR SITE. NOR WAS THE INFECTION DUE TO A SINUS TRACT/ABSCESS ASSOCIATED WITH A SUTURE SITE LOCATION. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS SENT TO PATHOLOGY ACCORDING TO HOSPITA
Patient problems: Unspecified Infection
MAUDE report 18133084 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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