TraumaOne SYSTEM 45-2008Recalls & reported problems
Biomet Microfixation, Inc · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888233000598), received between Mar 29, 2021 and Mar 29, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2021Fracture; Fracture
IT WAS REPORTED TWO (2) SCREWS FRACTURED DURING THE FIXATION OF A FOUR (4) HOLE PLATE. THE SHAFTS OF THE SCREWS REMAIN EMBEDDED IN THE PATIENT¿S BONE AND COULD NOT BE REMOVED. THE SCREW HOLE WAS LEFT EMPTY AND COULD NOT BE USED DUE TO THE SHAFT EMBEDDED IN THE BONE AND THIS RESULTED IN SUBOPTIMAL FIXATION OF THE PLATE. THERE WAS A DELAY OF A FEW MINUTES WHILE THE SURGEON AND SALES REP DELIBERATED OVER THE BEST COURSE FORWARD. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 11583035 ↗InjuryMar 29, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 11583019 ↗
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- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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