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NA 111640Recalls & reported problems

Mako Surgical Corp. · BONE PINS (4MM X 170MM) · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486001322), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1
  • Output Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjuryOct 31, 2019Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

    FEMUR FRACTURE AT PIN SITE. UPDATE 24/OCTOBER/2019 WG: AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: "SURGERY TO FIX FRACTURE". REP REPORTED THE PRIMARY SURGERY WAS "MAKO PKA USING 4.0 X 170 PINS."

    Patient problems: Bone Fracture(s)

    MAUDE report 9260073 ↗

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