BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2922482 · Received January 18, 2013

    Report

    Report Number
    1030489-2013-00165
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT WAS RETURNED FOR EVALUATION. FUNCTIONALLY EVALUATED THE INSTRUMENT'S RIGIDITY BY ATTEMPTING TO MANUALLY TIGHTEN THE INSTRUMENT. AFTER MANUAL TIGHTENING, THE INSTRUMENT WAS DETERMINED TO BE INSUFFICIENTLY RIGID. THE NATURE OF THE MECHANISM OF FAILURE IS CONSISTENT WITH ANTICIPATED WEAR OF THE INSTRUMENT CABLE.

    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.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28029 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA MY12E001

    Patients

    Seq Age Sex Outcome Treatment
    1