TraumaOne SYSTEM SP-2978Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of TRAUMAONE SYSTEM (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233021036), received between Aug 8, 2020 and Aug 8, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2020Fracture; Fracture
IT WAS REPORTED A PLATE FRACTURE WAS DISCOVERED TWO (2) DAYS POST-OPERATIVELY. THE RIGHT SUBCONDYLAR PLATE WAS PLACED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A MANDIBLE FRACTURE. THE FRACTURE WAS DISCOVERED BY POST-OPERATIVE CT SCAN. A REVISION WILL BE PERFORMED TO REMOVE THE FRACTURED IMPLANT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Information
MAUDE report 10383021 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- 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 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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