BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO ROBOTIC ARM 3.1

    MDR report key: 19441851 · Received June 1, 2024

    Report

    Report Number
    3005985723-2024-00069
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    May 9, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE 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

    REPORTED EVENT. AN EVENT REGARDING INCORRECT PLACEMENT INVOLVING A MAKO PKA SOFTWARE WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA PROVIDED WAS CORRUPT. ADDITIONAL REQUESTS FOR THE LOG FILES WERE ISSUED TO THE COMPLAINANT HOWEVER NO INFORMATION WAS RECEIVED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB920 WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: ROB920 SHOWS NO OTHER SIMILAR COMPLAINTS FOR PKA SOFTWARE - INCORRECT PLACEMENT. CONCLUSIONS: THE ALLEGED FAILURE MODE CANNOT BE DETERMINED BECAUSE THE RELEVANT LOG FILES AND SESSION FILES WERE NOT AVAILABLE FOR INSPECTION. 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

    AS ORIGINALLY REPORTED: "IMPLANT SHIFTED POSTERIOR. CASE TYPE / APPLICATION: PKA (MICS)" ADDITIONAL INFORMATION PROVIDED: A RESTORIS MCK RM PKA WAS IMPLANTED 13/MARCH/2024. IMPLANTS APPEAR TO BE POSTERIOR TO PLAN. IT IS BELIEVED THAT INACCURACY WITH THE ROBOT OR A BUMPED ARRAY WAS THE CAUSE. NO REVISION IS PLANNED AND NO PATIENT COMPLAINTS HAVE BEEN REPORTED AS OF 16/MAY/2024.

    Description of Event or Problem · 0

    AS ORIGINALLY REPORTED: "IMPLANT SHIFTED POSTERIOR. CASE TYPE / APPLICATION: PKA (MICS)". ADDITIONAL INFORMATION PROVIDED: A RESTORIS MCK RM PKA WAS IMPLANTED (B)(6) 2024. IMPLANTS APPEAR TO BE POSTERIOR TO PLAN. IT IS BELIEVED THAT INACCURACY WITH THE ROBOT OR A BUMPED ARRAY WAS THE CAUSE. NO REVISION IS PLANNED AND NO PATIENT COMPLAINTS HAVE BEEN REPORTED AS OF 16/MAY/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298668 MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. ROB920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O