BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2802767 · Received October 24, 2012

    Report

    Report Number
    1030489-2012-01957
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    87LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FUNCTIONAL EVALUATION WITH TWO SAMPLES WAS CONDUCTED. COULD NOT IDENTIFY ANY ISSUE IN RESPECT TO SECURELY HOLDING OR RELEASING THE IMPLANT AS INTENDED. UNABLE TO REPLICATE CONCERN. AFTER VISUAL REVIEW AND FUNCTIONAL EVALUATION, THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENTS WILL NOT RELEASE THE IMPLANT ONCE INSIDE THE PATIENT; INSTRUMENTS ARE STICKING. ALTHOUGH THE INSTRUMENTS WERE USED IN SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA MN12F012

    Patients

    Seq Age Sex Outcome Treatment
    1