Cerafix® Dura Substitute C1-2X2Recalls & reported problems
Acera Surgical Inc · Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. · 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 00854258006020), received between Sep 1, 2020 and Sep 1, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Cerebrospinal Fluid Leakage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PATIENT RETURNED 2 WEEKS POST-OP WITH A CSF LEAK.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 10479858 ↗
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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