CRANIOPLASTIC 43-1280Recalls & reported problems
Cerenovus, Inc. · Codman CRANIOPLASTIC Resinous Material for Repairing Cranial Defects · Class 2 · Implant
Data updated Oct 18, 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 10886704015505), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
MalfunctionApr 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED AN EXPIRED CRANIOPLASTIC CEMENT ((B)(6)) WAS USED IN A CRANIOPLASTY SURGERY ON (B)(6) 2024. THE PRODUCT WAS EXPIRED SINCE JANUARY 31, 2024 AND WAS NOT CHECKED BEFORE USE. NO PATIENT INJURY REPORTED AN THE EVENT DID NOT LED TO SURGICAL DELAY. THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091178 ↗
Other METHYL METHACRYLATE FOR CRANIOPLASTY devices
- Direct Inject 79-45905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY1 recall7 reports
- CRANIOS Reinforced 615.05.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY17 reports
- CRANIOS Reinforced 615.10.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY11 reports
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- CRANIOS Reinforced 615.03.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- HYDROSET 79-43910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- StaGraft DBM Putty 92-2004Biomet Orthopedics, LLC · Methyl Methacrylate For Cranioplasty3 reports
- Direct Inject 79-45903Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 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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