BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER- STRAIGHT SHELL

    MDR report key: 4888323 · Received July 2, 2015

    Report

    Report Number
    3005985723-2015-00120
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT FAILURES WERE REPORTED. DURING A SURGICAL PROCEDURE, A SURGEON COMMENTED THAT THE THREADS DON'T SEEM LIKE THEY WOULD HOLD ONTO THE CUP VERY WELL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE CASE, SURGEON WANTED TO USE THE MANUAL THREADED CUP IMPACTOR TO SECONDARY IMPACT THE CUP. THERE ARE VERY LIMITED THREADS ON THE IMPACTOR TO SCREW IN THE CUP IMPLANT. IT WAS VERY DIFFICULT TO THREAD INTO THE CUP, AND HE FORESEES IT BEING AN ISSUE DOWN THE ROAD, ESPECIALLY IF WE HAVE TO EVER TAKE A CUP OUT. THE THREADS DON'T SEEM LIKE THEY WOULD HOLD ONTO THE CUP VERY WELL.

    Description of Event or Problem · 1

    DURING THE CASE, SURGEON WANTED TO USE THE MANUAL THREADED CUP IMPACTOR TO SECONDARY IMPACT THE CUP. THERE ARE VERY LIMITED THREADS ON THE IMPACTOR TO SCREW IN THE CUP IMPLANT. IT WAS VERY DIFFICULT TO THREAD INTO THE CUP, AND HE FORESEES IT BEING AN ISSUE DOWN THE ROAD, ESPECIALLY IF WE HAVE TO EVER TAKE A CUP OUT. THE THREADS DON'T SEEM LIKE THEY WOULD HOLD ONTO THE CUP VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432059 INSERTER- STRAIGHT SHELL INSTRUMENT OQG MAKO SURGICAL CORP. 120112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other