DuraGen® Plus DP1022Recalls & reported problems
Integra Lifesciences Corporation · DuraGen® Plus Dural Regeneration Matrix, 2 in x 2 in (5 cm x 5 cm) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780023456), received between Dec 7, 2023 and Dec 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Seal” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Seal1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2023Failure to Seal; Failure to Seal
A FACILITY REPORTED THAT WHEN INTRODUCING THE DURA GRAFT TRANSPHENOIDALLY, WHEN PASSING THROUGH THE NASAL DUCT, THE DURAGEN PLUS DURAL REGENATION MATRIX 2X2 (DP1022) BECAME A BALL THAT WAS DIFFICULT TO MANIPULATE. THE PHYSICIAN COULD NOT EXTEND IT IN ITS ENTIRETY AT THE SURGICAL SITE, SO IT WAS LEFT IN THE FORM OF A PLUG AND FILLED WITH A TESSEL-TYPE FIBRIN SEALANT TO GUARANTEE CLOSURE AND AVOID FISTULA IN THE POST-OPERATIVE PERIOD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18284680 ↗
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
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62110Medtronic Ps Medical, 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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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