BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER

    MDR report key: 1991505 · Received February 15, 2011

    Report

    Report Number
    1030489-2011-00129
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTERBODY DEVICE, THE INSERTER DETACHED FROM THE DEVICE. PER THE REPORTER, THIS WAS CAUSED BY THE HAMMERING ON THE INSERTER, WHICH VIBRATES THE THUMBWHEEL, WHICH THEN CAUSES THE THUMBWHEEL TO TURN SO THE INTERBODY DEVICE AND INSERTER DETACH. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTER SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1