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Mako 110135Recalls & reported problems

Mako Surgical Corp. · Ball Burr · Class 2

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 00848486016876), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible Results” (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

  • Non Reproducible Results1
  • Use of Device Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionSep 25, 2018Use of Device Problem; Non Reproducible Results; Use of Device Problem; Non Reproducible Results

    DURING FEMUR SURFACE BURRING. BURR CAUGHT TIP OF SURGEONS GLOVE WHILE SHE PRESSED TRIGGER. NO HARM TO SURGEON, JUST CAUGHT GLOVE. CASE TYPE: PKA. PICTURE IS NOT FROM DURING SURGERY - IT SHOWS US TRYING TO REPLICATE WHAT MAY HAVE HAPPENED. IT LOOKED LIKE HER GLOVE WAS LOOSE AND GOT CAUGHT UP BY THE BURR AS POWER WAS ENGAGED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7908098 ↗

Other Orthopedic stereotaxic instrument devices

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