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TRAUMAONE SYSTEM 91-5609Recalls & reported problems

Biomet Microfixation, Inc · Class 2

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 00841036135423), received between Oct 10, 2019 and Dec 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Patient-Device Incompatibility1

Patient problems

  • Difficulty Chewing1
  • No Information1
  • Pain1
  • Sleep Dysfunction1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Patient problems: No Information

    MAUDE report 9520364 ↗
  • InjuryOct 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Patient problems: Difficulty Chewing; Pain; Sleep Dysfunction

    MAUDE report 9177314 ↗

Other SCREW, FIXATION, INTRAOSSEOUS devices

All SCREW, FIXATION, INTRAOSSEOUS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.