DURAFORMRecalls & reported problems across all models

We found 4 models of DURAFORM by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2018 and Mar 13, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Contamination With Biological Material” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DURAFORM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 26, 2024Open, Classified

   Out of specification endotoxin levels.

   Z-0262-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported DURAFORM problems

DURAFORM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DURAFORM 80-1477US

  DURA SUBSTITUTE
  1 recall0 reports
• DURAFORM 80-1474

  DURA SUBSTITUTE
  1 report
• DURAFORM 80-1478

  DURA SUBSTITUTE
  1 report
• DURAFORM 80-1480

  DURA SUBSTITUTE
  1 report

Recent DURAFORM adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER A PROCEDURE INVOLVING DURAFORM, PATIENT DEVELOPED MENINGITIS. A SECOND SURGERY WAS DONE TO CLEAN THE IMPLANT SITE.

  Patient problems: Meningitis

  MAUDE report 8418319 ↗
• InjuryApr 18, 2018Device Contamination With Biological Material; Device Contamination With Biological Material; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED ON A SPREADSHEET WHICH NATUS RECEIVED FROM CODMAN ON 19MARCH2018: "A PATIENT DEVELOPED AN INFECTION AFTER DURAFORM WAS USED AND A REVISION SURGERY WAS PERFORMED." EVENT DATE: DEC. UNK. A SURGEON REVISED A SURGERY AFTER SEVERAL DAYS OF INITIAL SURGERY DUE TO INFECTION. THEY FOUND DURAFORM WAS INFECTED BY CERTAIN TYPES OF BACTERIA. HE SAID HE SAW SEVERAL CASES OF INFECTION ON DURAFORM. SURGEON FEELS THAT THE DEVICE CONTRIBUTED TO THE PROBLEM. DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Unspecified Infection

  MAUDE report 7440301 ↗
• InjuryApr 17, 2018Device Contamination With Biological Material; Microbial Contamination of Device; Device Contamination With Biological Material

  THE FOLLOWING WAS REPORTED ON A SPREADSHEET WHICH NATUS RECEIVED FROM CODMAN ON 19MARCH2018: "A PATIENT DEVELOPED AN INFECTION AFTER DURAFORM WAS USED AND A REVISION SURGERY WAS PERFORMED." EVENT DATE: (B)(6). UNK A SURGEON REVISED A SURGERY AFTER SEVERAL DAYS OF INITIAL SURGERY DUE TO INFECTION. THEY FOUND DURAFORM WAS INFECTED BY CERTAIN TYPES OF BACTERIA. HE SAID HE SAW SEVERAL CASES OF INFECTION ON DURAFORM. SURGEON FEELS THAT THE DEVICE CONTRIBUTED TO THE PROBLEM. DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Unspecified Infection

  MAUDE report 7438568 ↗

Other Cerenovus, Inc. products

• GALAXY G358 models · 1,386 reports · 1 recall
• CODMAN41 models · 107 reports · 22 recalls
• MICRUSFRAME47 models · 298 reports
• DELTAFILL29 models · 294 reports
• CEREPAK FREEFORM60 models · 166 reports · 1 recall
• CEREBASE3 models · 143 reports · 1 recall
• DELTAXSFT13 models · 130 reports
• CEREPAK UNIFORM58 models · 33 reports · 1 recall