BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE-STRAIGHT BROACH

    MDR report key: 6078998 · Received November 4, 2016

    Report

    Report Number
    0002249697-2016-03450
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 7, 2016
    Report Date
    May 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A BROACH HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS MISPLACED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: TWO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. CONCLUSIONS: THE FAILURE COULD NOT BE CONFIRMED NOR A ROOT CAUSE DETERMINED AS THE DEVICE WAS RETURNED AND MISPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    BROACH HANDLE LOCKING PIN CAME OUT.

    Description of Event or Problem · 1

    BROACH HANDLE LOCKING PIN CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731530 HANDLE-STRAIGHT BROACH HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG MAKO SURGICAL CORP. 110045

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other