BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2964127 · Received February 15, 2013

    Report

    Report Number
    1030489-2013-00522
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FUNCTIONALLY EVALUATED FLEX ARM RIGIDITY BY ATTEMPTING TO MANUALLY TIGHTEN THE INSTRUMENT. AFTER MANUAL TIGHTENING, THE INSTRUMENT WAS INSUFFICIENTLY RIGID. THE NATURE OF THE MECHANISM OF FAILURE IS CONSISTENT WITH ANTICIPATED WEAR OF THE INSTRUMENT CABLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINAL SURGERY THAT THE FLEX ARM WOULD NOT TIGHTEN. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68743 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA MY12C001

    Patients

    Seq Age Sex Outcome Treatment
    1