BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 3242722 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04381
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES WERE FOUND THAT WOULD CONTRIBUTE TO THE REPORTED CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS THE NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED T-PAL SPACER APPLICATOR WAS USED FOR THE INTERBODY CAGE DURING THE PROCEDURE. THE T-PAL APPLICATOR WOULD NOT RELEASE FROM THE CAGE ONCE IMPLANTED. WHEN THE SURGEON WAS ABLE TO REMOVE THE APPLICATOR THE FORK PORTION OF THE APPLICATOR WAS OBSERVED TO BE DEFORMED. THE CAGE WAS IMPLANTED IN THE CANAL AND THE SURGEON IMMEDIATELY TRIED TO REMOVE THE CAGE. THE CAGE CAME OUT BROKEN. THE SURGEON REPORTED DAMAGE TO THE PATIENTS SPINAL CORD. THE SURGEON BELIEVES THE PATIENT WILL BE PARAPLEGIC. THIS REPORT IS FOR THE T-PAL SPACER APPLICATOR KNOB. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    THIS FOLLOW UP IS BEING SENT BECAUSE OF A FACILITY MEDWATCH RECEIVED. THE FACILITY MEDWATCH WILL BE ATTACHED ALONG WITH THIS MEDWATCH, AND ANY INFORMATION FROM THE FACILITY MEDWATCH WILL NOT BE REPEATED IN THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342966 T-PAL SPACER APPLICATOR KNOB LXH SYNTHES GMBH 8356820

    Patients

    Seq Age Sex Outcome Treatment
    1