DURA-GUARD Dural Repair Patch DG0608SNRecalls & reported problems
Synovis Life Technologies, Inc. · DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile. · Class 2 · Implant
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 00085412531007), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Headache1
- Inflammation1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT EXPERIENCED HEADACHES, INFLAMMATION AND AN UNSPECIFIED INFECTION AFTER UNDERGOING A SURGERY FOR CHIARI MALFORMATION IN WHICH DURA-GUARD WAS PLACED SUBOCCIPITALLY. IT WAS REPORTED THE PATIENT EXPERIENCED SURGICAL PAIN AND HEADACHES THE DAY AFTER THE SURGERY. APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS STILL EXPERIENCING HEADACHES AND A MONTH LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH HEADACHES. APPROXIMATELY FOUR MONTHS AFTER THE SURGERY, THE PATIENT EXPERIENCED PRESSURE DUE TO A LARGE FLUID COLLECTION IN THE AREA OF THE IMPLANT. APPROXIMATELY 133 DAYS AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT A SURGERY DUE TO AN INFLAMMATORY RESPONSE FROM THE DURA-GUARD; SUBSEQUENTLY THE DURA-GUARD WAS REMOVED. ON AN UNREPORTED DATE DURING HOSPITALIZATION, THE PATIENT RECEIVED VANCOMYCIN VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) FOR AN UNSPECIFIED INFECTION (NO FURTHER DETAILS). ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED WITH THE PICC LINE TO CONTINUE ANTIBIOTIC TREATMENT AT HOME. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Headache; Inflammation; Unspecified Infection
MAUDE report 8436720 ↗
Other DURA SUBSTITUTE devices
- Durepair® 62100Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall6 reports
- Durepair® 62105Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall5 reports
- Durepair® 62110Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall3 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62111Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62106Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Biodesign G31091Cook Biotech Incorporated · DURA SUBSTITUTE1 recall0 reports
- Biodesign G31091Cook Biotech Incorporated · DURA SUBSTITUTE1 recall0 reports
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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