BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATOR INNER SHAFT

    MDR report key: 2971952 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00579
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    October 11, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION, DATE UNKNOWN. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE APPLICATOR WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. WE HAVE FORWARDED THE COMPLAINED ARTICLE TO THE RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR EVALUATION. THE INVESTIGATION SHOWS THAT THE TIP OF THE APPLICATOR INNER SHAFT IS SLIGHTLY DEFORMED. A HANDLING TEST WAS PERFORMED AND THE IMPLANT CAME NORMALLY OFF. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON TRIED TO DETACH IMPLANT FROM TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR CAGE SYSTEM (T-PAL) APPLICATOR, BUT THE APPLICATOR DID NOT COME OFF DUE TO T-PAL INNER SHAFT MALFUNCTION. THE APPLICATOR WAS DISSEMBLED, IN SITU, AND THE IMPLANT WAS LEFT WITH PATIENT. THIS IS 1 OF 1 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75363 APPLICATOR INNER SHAFT APPLICATOR INNER SHAFT LXH SYNTHES GMBH 3741205

    Patients

    Seq Age Sex Outcome Treatment
    1