TRAUMAONE SYSTEM 41-2010 (UDI 00841036124625)Recalls & 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 00841036124625), received between Nov 21, 2022 and Nov 21, 2022 — 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.
InjuryNov 21, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE PLACEMENT OF A PLATE THE SCREW FRACTURED. THE PLATE WAS REPOSITIONED AND DIFFERENT, LONGER SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE. THE BODY OF THE SCREW REMAINS INSIDE THE PATIENT'S BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 15838310 ↗InjuryNov 21, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE PLACEMENT OF A PLATE THE SCREW FRACTURED. THE PLATE WAS REPOSITIONED AND DIFFERENT, LONGER SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE. THE BODY OF THE SCREW REMAINS INSIDE THE PATIENT'S BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 15835833 ↗
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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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