BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL TRIAL SPACER 10MM X 28MM7MM HEIGHT

    MDR report key: 3101346 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02452
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION SURGERY ON (B)(6) 2013, THE SURGEON WAS USING THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SYSTEM (T-PAL). THE SURGEON TRIALED FOR THE APPROPRIATE IMPLANT SIZE USING THE T-PAL TRIAL INSTRUMENT. HE THEN USED THE T-PAL SLAP HAMMER TO ATTEMPT TO EXTRACT THE TRIAL FROM THE DISC SPACE WHEN SUDDENLY THE BASE OF THE SLAP HAMMER, WHERE IT ATTACHES TO IMPLANT INSERTER BROKE OFF. SURGEON PROCEEDED TO USE THE OPAL SLAP HAMMER TO REMOVE THE INSERTER AND TRIAL DEVICE SUCCESSFULLY. UPON DOING THIS, SURGEON REALIZED THAT THE TRIAL SPACER HAD BROKEN. REPORTEDLY THE TRIAL SPACER BROKE OFF THE BALL AT THE END OF THE TRIAL SPACER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON WIGGLED THE TRIAL SPACER OUT WITH A PAIR OF VICE GRIPS SEEING AS IT HAD BECOME DETACHED TO THE T-PAL SPACER APPLICATOR HANDLE VIA THE BREAK OF THE BALL AT THE END OF THE TRIAL SPACER INNER SHAFT. SURGEON THEN LOADED UP THE APPROPRIATE IMPLANT T-PAL SPACER INTO THE T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT. AS SURGEON BEGAN INSERTING THE IMPLANT INTO THE PATIENT, THE T-PAL SPACER APPLICATOR INNER SHAFT BROKE. THE T-PAL SPACER APPLICATOR INNER SHAFT BROKE IN THE EXACT SAME SPOT AS THE TRIAL SPACER INNER SHAFT DID PREVIOUSLY. IT BROKE OFF THE BALL AT THE END OF THE SPACER APPLICATOR INNER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON THEN PLACED THE ORIGINAL IMPLANT ONTO A NEW T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT. THE SURGEON BEGAN INSERTING, AND THE SPACER APPLICATOR INNER SHAFT BROKE AGAIN IN THE EXACT SAME LOCATION AS THE OTHER SPACER APPLICATOR INNER SHAFT AND TRIAL SPACER INNER SHAFT. IT BROKE OFF THE BALL AT THE END OF THE SPACER APPLICATOR INNER SHAFT THAT IS USED TO SECURE IT INTO THE T-PAL SPACER APPLICATOR HANDLE. SURGEON THEN PLACED THE ORIGINAL IMPLANT ONTO A NEW T-PAL SPACER APPLICATOR HANDLE AND T-PAL SPACER APPLICATOR INNER SHAFT AND FINALLY SUCCESSFULLY IMPLANTED THE T-PAL SPACER. IT WAS REPORTED THAT AN ADDITIONAL 20 MINUTES WAS ADDED TO SURGERY TIME. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204067 T-PAL TRIAL SPACER 10MM X 28MM7MM HEIGHT HWT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention