BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO ROBOTIC ARM 3.1

    MDR report key: 20833899 · Received December 3, 2024

    Report

    Report Number
    3005985723-2024-00271
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 15, 2024
    Report Date
    April 8, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING REGISTRATION FAILS INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE ROBOT WAS NOT INSPECTED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: A REQUEST FOR A FIELD SERVICE ENGINEER INSPECTION WAS NOT MADE AND THE ROBOT WAS NOT INSPECTED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED AS THERE HAS BEEN NO ONSITE INSPECTION BY A FIELD SERVICE ENGINEER. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA.

    Description of Event or Problem · 0

    MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210044 MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other