BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR HANDLE

    MDR report key: 5439322 · Received February 16, 2016

    Report

    Report Number
    3003875359-2016-10108
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 26, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    PMA / PMN Number
    PK151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (T-PAL SPACER APPLICATOR HANDLE, PART NUMBER 03.812.001, LOT NUMBER 9063526). THE SUBJECT DEVICE WAS RECEIVED WITH THE ASSOCIATED APPLICATOR INNER SHAFT AND APPLICATOR KNOB FOR THE COMPLAINT AS FOLLOWS, ¿IT WAS REPORTED THAT DURING A T-PAL PROCEDURE, A FRAGMENT OF THE IMPLANT SPACER BROKE OFF WHILE ATTEMPTING TO RELEASE IT FROM THE APPLICATOR ASSEMBLY. THE SURGEON HAD DIFFICULTY MANEUVERING THE SPACER INTO POSITION AND, ONCE IN POSITION, HAD DIFFICULTY TURNING THE APPLICATOR KNOB TO RELEASE THE IMPLANT. THE IMPLANT WAS EVENTUALLY ABLE TO BE RELEASED, BUT A SMALL FRAGMENT OF THE SPACER BROKE OFF. THE FRAGMENT WAS ABLE TO BE RETRIEVED AND THE SPACER WAS LEFT IN PLACE. THERE WAS A 20 MINUTE SURGICAL DELAY AS A RESULT.¿ PLEASE NOTE, THE IMPLANT FRAGMENT WAS NOT RETURNED. THE RETURNED INSTRUMENTS ARE UTILIZED IN THE T-PAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR) SYSTEM. AFTER TRIALING, THE APPLICATOR INNER SHAFT IS INSTALLED INTO THE APPLICATOR HANDLE/KNOB ASSEMBLY UNTIL THE RELEASE BUTTON CLICKS INTO PLACE. THE APPROPRIATE SPACER IS ATTACHED BY ROTATING THE KNOB CLOCKWISE UNTIL THE SECURITY RING CLICKS INTO POSITION DISPLAYING A GREEN BAND. THE KNOB CAN THEN CONTINUE TO BE ROTATED CLOCKWISE UNTIL TIGHT; THE IMPLANT WILL NOT PIVOT IN THIS POSITION. THE IMPLANT CAN THEN BE ADVANCED INTO THE INTERVERTEBRAL DISC SPACE WITH LIGHT HAMMERING. ONCE IN POSITION THE APPLICATOR KNOB IS ROTATED COUNTERCLOCKWISE UNTIL IT STOPS AT THE SECURITY RING, ALLOWING THE IMPLANT TO PIVOT. THE IMPLANT CAN BE ADVANCED INTO THE FINAL POSITION WITH LIGHT CONTROLLED HAMMERING. ONCE THE IMPLANT IS IN POSITION, IT CAN BE DETACHED BY PUSHING THE SECURITY RING DOWN AND SIMULTANEOUSLY TURNING THE APPLICATOR KNOB COUNTERCLOCKWISE UNTIL IT STOPS; THE APPLICATOR CAN THEN BE REMOVED FROM THE SPACER PER THE TECHNIQUE GUIDE. THE PRODUCT DRAWING WAS REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THE DEVICE. AS PREVIOUSLY REPORTED, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. FUNCTIONAL TESTING WAS PERFORMED USING THE SUBJECT DEVICE AND ITS ASSOCIATED INSTRUMENTS. THE DEVICES WERE ABLE TO BE ASSEMBLED AND WERE FOUND TO FUNCTION AS INTENDED. AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED, THE COMPLAINT IS UNCONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF INCORRECT TECHNIQUE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. COMMON DEVICE NAME: ADDITIONAL DEVICE PRODUCT CODE IS LXH. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 THAT DURING THE PATIENT'S INITIAL SURGERY ON (B)(6) 2016, FOR IMPLANTATION OF TWO-LEVEL TRANSFORMATIONAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACERS WITH PEDICEL SCREWS AND RODS CONSTRUCT AT L4- S1 DISC LEVELS, A FRAGMENT OF THE T-PAL IMPLANT BROKE OFF AT THE L5-S1 POSITION. WHILE THE SURGEON WAS INSTRUMENTING AT THE L5-S1 LEVEL THE TRIAL SPACER WAS REMOVED AND THE IMPLANT WAS INTRODUCED. THE SPACER WAS DIFFICULT TO MANEUVER INTO PLACE AND REQUIRED A SIGNIFICANT AMOUNT OF FORCE TO SATISFACTORY TURN THE IMPLANT. AFTER SURGEON ACHIEVED ACCEPTABLE IMPLANT POSITION THE HANDLE KNOB OF THE INSTRUMENT COULD NOT BE TURNED TO RELEASE THE IMPLANT. THE RING WAS DEPRESSED BUT THE KNOB WOULD NOT TURN EVEN WITH CONSIDERABLE FORCE. FINALLY, APPLICATOR HANDLE WAS DISLODGED BUT A SMALL FRAGMENT OF THE T-PAL IMPLANT BROKE OFF. SURGEON LEFT THE IMPLANT IN PLACE AT THE L5-S1 DISC LEVEL AND THE SMALL FRAGMENT WAS RETRIEVED AND DISPOSED OF BY THE HOSPITAL. SURGERY WAS COMPLETED SUCCESSFULLY. A TWENTY MINUTE SURGICAL DELAY OCCURRED DUE TO THE REPORTED EVENT. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94818 T-PAL SPACER APPLICATOR HANDLE INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF 9063526

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR