BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR SYNFIX(TM)-LR

    MDR report key: 2960565 · Received February 14, 2013

    Report

    Report Number
    2520274-2013-00917
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    December 14, 2010
    Manufacturer
    SYNTHES
    Product Code
    LXH
    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 EXEMPT. 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 THE TIP OF IMPLANT HOLDER BROKE OFF IN IMPLANT, (B)(4), WHILE BEING INSERTED INTO THE PATIENT. A SECOND IMPLANT WAS OPENED IN PREPARATION FOR THE INITIAL IMPLANT TO BE REMOVED BUT THE SURGEON DECIDED TO PROCEED WITH THE ORIGINAL IMPLANT AND LEAVE IT INSITU. THE SCREWS WERE INSERTED WITHOUT FURTHER ISSUE AND THE PATIENT CLOSED. THE LOAN SET WILL BE DECONTAMINATED AND RETURNED FOR MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64826 IMPLANT HOLDER FOR SYNFIX(TM)-LR IMPLANT HOLDER FOR SYNFIX LXH SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1