BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2970187 · Received February 20, 2013

    Report

    Report Number
    3003529816-2013-00006
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TO IMPLANT THE DISTRACTABLE CAGE, THE THREADED PORTION OF THE DISTRACTION ROD SHEARED OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73853 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ADVANCED MEDICAL TECHNOLOGIES NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1