StaGraft DBM Putty 92-2004Recalls & reported problems
Biomet Orthopedics, LLC · Demineralized Bone Matrix (DBM) in a Lipid Carrier · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304684867), received between Mar 15, 2021 and Mar 15, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 reports).
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.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11484953 ↗MalfunctionMar 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A FACILITY DISCOVERED THREE PACKAGES WITH HOLES IN THE INTERIOR STERILE WRAP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11484947 ↗MalfunctionMar 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A FACILITY DISCOVERED THREE PACKAGES WITH HOLES IN THE INTERIOR STERILE WRAP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11484902 ↗
Other Methyl Methacrylate For Cranioplasty devices
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- CRANIOS Reinforced 615.10.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY11 reports
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- HYDROSET 79-43910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- CRANIOS Reinforced 615.03.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- HYDROSET 79-43905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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