DuraGen® Plus DP1013Recalls & reported problems
Integra Lifesciences Corporation · DuraGen® Plus Dural Regeneration Matrix, 1 in x 3 in (2.5 cm x 7.5 cm) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780023449), received between Oct 2, 2025 and Oct 3, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K032693); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
Patient problems
- Cerebrospinal Fluid Leakage3
- Post Operative Wound Infection3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
N/A.
Patient problems: Cerebrospinal Fluid Leakage; Post Operative Wound Infection
MAUDE report 23213157 ↗InjuryOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT IS FOR THE 3RD INFECTION CASE AND IS LINKED TO MFG REPORT NUMBERS 1121308-2025-00032 AND 1121308-2025-00033: A FACILITY REPORTED THAT DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC (DP1013) WAS USED DURING SPINAL SURGERY, AND DURAL LEAKS WERE OBSERVED. ADDITIONALLY, THERE WERE 3 INFECTION CASES DURING (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Cerebrospinal Fluid Leakage; Post Operative Wound Infection
MAUDE report 23213153 ↗InjuryOct 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT IS FOR THE 1ST INFECTION CASE AND IS LINKED TO MFG REPORT NUMBERS 1121308-2025-00033 AND 1121308-2025-00034: A FACILITY REPORTED THAT DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC (B)(6)) WAS USED DURING SPINAL SURGERY, AND DURAL LEAKS WERE OBSERVED. ADDITIONALLY, THERE WERE 3 INFECTION CASES DURING JULY/AUGUST. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Cerebrospinal Fluid Leakage; Post Operative Wound Infection
MAUDE report 23204069 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032693. One submission often covers many models, so check the product and lot details in each record.
- Z-1284-2013 · Mar 28, 2013 · TerminatedDuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the
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
- Durepair® 62158Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall0 reports
- DURAFORM 80-1477USCerenovus, Inc. · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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