BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 8633090 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00375
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: ANSPACH EMAX 2 PLUS BURR MOTOR COULD NOT LOCK BURR IN PLACE. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING ANSPACH EMAX 2 PLUS BURR MOTOR COULD NOT LOCK BURR IN PLACE FAILURE OF P/N: 110940, S/N: F39306998007. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REFERENCED SERIAL NUMBER. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: AS THE EVENT DID NOT INVOLVE A MANUFACTURING RELATED PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND, OR UNANTICIPATED HAZARD, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    ANSPACH COULD NOT LOCK BURR IN PLACE. CASE TYPE: PKA. SURGICAL DELAY: X 16-30 MINUTES.

    Additional Manufacturer Narrative · 1

    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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ANSPACH COULD NOT LOCK BURR IN PLACE. CASE TYPE: PKA . SURGICAL DELAY: X 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424079 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization