BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 4339003 · Received December 17, 2014

    Report

    Report Number
    3003875359-2014-10420
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 18, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT, NOT IMPLANTED OR EXPLANTED. THE PART WAS RECEIVED; AN EVALUATION IS CURRENTLY IN PROGRESS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE T-PAL SPACER APPLICATOR INNER SHAFT BELONGS TO THE T-PAL SPACER SYSTEM; THESE SPACERS ARE FOR USE IN PATIENTS WITH DEGENERATIVE DISC DISEASE. THIS DEVICE IS COUPLED WITH AN APPLICATOR HANDLE AND AN APPLICATOR KNOB FOR IMPLANT INSERTION. ONE T-PAL SPACER APPLICATOR INNER SHAFT (PART# 03.812.003, LOT# 855054, MFG. DEC2012) WAS RETURNED WITH THE COMPLAINT THAT ¿INSERTER WOULD NOT COME OFF THE IMPLANT. THE INSERTER WAS TAKEN OFF THE INSERTER SHAFT AND THE IMPLANT WAS UN-ROTATED AND THE SHAFT WAS PULLED OFF USING SOME FORCE. A TAMP WAS USED TO FINAL POSITION THE IMPLANT.¿ UPON RECEIPT OF THE DEVICE IT WAS SEEN THAT THE TWO DISTAL ¿ARMS¿ OF THE APPLICATOR WERE NO LONGER IN PARALLEL WITH EACH OTHER, AS THERE IS A 4.1MM DIFFERENCE IN PLANE LOCATION. AS THE DEVICE IS PERMANENTLY DEFORMED IN A MANNER WHICH WOULD AFFECT ITS FUNCTION, THIS COMPLAINT IS CONFIRMED. THE DRAWING FOR THIS DEVICE WAS REVIEWED ((B)(4)) AS WELL AS THAT OF THE SPACERS FOR WHICH THIS INSTRUMENT IS USED TO INSERT ((B)(4)), THESE DESIGNS, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE ADEQUATE FOR THEIR INTENDED APPLICATIONS. IT IS LIKELY THAT ROTATIONAL FORCE WAS APPLIED DURING THE INSERTION PROCESS, RESULTING IN THE BENT CONDITION OF THIS INSTRUMENT, WHICH WOULD CAUSE THE INSERTER TO BE DIFFICULT TO REMOVE FROM THE IMPLANT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A 12MM 10X28 TPAL SPACER WAS BEING INSERTED AT L4-L5 DISC SPACE OF A PATIENT. AFTER THE IMPLANT INSERTION AND ROTATION THE SURGEON PUSHED THE RING DOWN AND TURNED THE KNOB COUNTERCLOCKWISE TO REMOVE THE INSERTER. THE INSERTER WOULD NOT COME OFF THE IMPLANT. THE INSERTER WAS REMOVED FROM THE INSERTER SHAFT, THE IMPLANT WAS UN-ROTATED AND THE SHAFT WAS PULLED OFF USING SOME FORCE. A TAMP WAS USED TO FINAL POSITION THE IMPLANT. THE PATIENT ALSO HAD COMPETITORS SCREWS IMPLANTED FROM L4-S1. THERE WAS NO DELAY IN SURGERY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS 1 OF 2 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828676 T-PAL SPACER APPLICATOR INNER SHAFT MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8155054

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR