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N/A 09-0340Recalls & reported problems

Biomet Microfixation, Inc · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036028855), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 15, 2020Fracture; Fracture

    IT WAS REPORTED THE TIP OF THE INSTRUMENT BROKE WHILE REMOVING A TOOTH ROOT TIP. THE FRACTURED PIECE OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10687174 ↗

Other ELEVATOR, SURGICAL, DENTAL devices

All ELEVATOR, SURGICAL, DENTAL devices →

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