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N/A 01-3906Recalls & reported problems

Biomet Microfixation, Inc · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841036011239), received between Jun 21, 2019 and Jun 22, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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

  • Physical Resistance/Sticking3
  • Mechanical Problem2
  • Activation Problem1
  • Mechanical Jam1

Patient problems

  • No Known Impact Or Consequence To Patient4
  • No Patient Involvement2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 22, 2020Mechanical Jam; Mechanical Jam

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

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10179878 ↗
  • MalfunctionApr 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THE TABLE TOP BENDER WAS HARD TO MOVE DURING A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9953983 ↗
  • MalfunctionApr 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THE TABLE TOP BENDER WAS HARD TO MOVE DURING A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9953974 ↗
  • MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

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

    Patient problems: No Patient Involvement

    MAUDE report 9218213 ↗
  • MalfunctionOct 21, 2019Mechanical Problem; Mechanical Problem

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

    Patient problems: No Patient Involvement

    MAUDE report 9215805 ↗
  • MalfunctionJun 21, 2019Physical Resistance/Sticking; Activation Problem; Physical Resistance/Sticking; Activation Problem

    IT WAS REPORTED THAT THE BENDER HANDLE WOULD NOT ENGAGE WITH THE BENDER TO BEND THE BAR. THERE WAS A SURGICAL DELAY OF 3-4 MINUTES AS THEY GRABBED ANOTHER BENDER TO BEND THE BAR. THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8723605 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

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