BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTS SPINE

    MDR report key: 2960135 · Received February 13, 2013

    Report

    Report Number
    2520274-2013-00891
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    November 29, 2010
    Manufacturer
    SYNTHES
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) REPORTED A SYNEX II COLLAPSED AND THE SCREWS BROKE. THE COLLAPSE WAS DETECTED 21 MONTHS AFTER. THE CAUDAL SCREWS OF THE ANTERIOR FIXATION, TSLP, WERE BROKEN. NO REVISION SURGERY WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62383 IMPLANTS SPINE IMPLANTS SPINE MQP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1