BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR ASSY, J3

    MDR report key: 8871216 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00569
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 24, 2019
    Report Date
    December 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS ASHLEY NEWTON REPORTED JOINT ANGLE ERROR AND FAILED HOMING ON M3. DEVICE EVALUATION AND RESULTS: PER (B)(4): REPLACED J3 MOTOR. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 03/01/17 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 17-02-0057, QT 17-02-0051, QT 17-02-0060. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 207569 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4), MPS ASHLEY NEWTON REPORTED JOINT ANGLE ERROR AND FAILED HOMING ON M3. CASE TYPE: THA. UPDATE: SURGICAL DELAY: > 30 MINUTES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CASE NUMBER: (B)(4), MPS (B)(6) REPORTED JOINT ANGLE ERROR AND FAILED HOMING ON M3. CASE TYPE: THA. UPDATE: SURGICAL DELAY: > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663891 MOTOR ASSY, J3 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. ROB539

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization