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NA 110800Recalls & reported problems

Mako Surgical Corp. · BLUNT PROBE · 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 00848486002695), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Material Integrity 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.

  • MalfunctionAug 3, 2018Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

    THE TIP OF THE GREEN PROBE BECAME DETACHED FROM THE ARRAYS. THIS CAUSED A PROBLEM WITH THE VERIFICATION OF THE CALIBRATION. CASE TYPE: TKA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7747770 ↗

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.