BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 5663319 · Received May 18, 2016

    Report

    Report Number
    2520274-2016-12731
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 3, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    PMA / PMN Number
    PK151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE T-PAL APPLICATOR INNER SHAFT (PART 03.812.003, LOT UNKNOWN) WOULD NOT RELEASE THE SPACER. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. TWO INNER SHAFTS (PART 03.812.003; LOTS 9831468 (MFG 04/2016), 9858948 (MFG 05/2016)) WERE RETURNED WITH TWO (2) APPLICATOR HANDLES (PART 03.812.001, LOTS 3473814 AND 3667762) AND TWO (2) KNOBS (PART 03.812.004, LOTS 9858938, 8761947). AS IT WAS UNKNOWN AS TO WHICH LOTS CONTRIBUTED TO THE COMPLAINT CONDITION, ALL THE DEVICES TESTED. 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. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED CONCOMITANT DEVICES (HANDLE: PART 03.812.001 (QTY. 2) AND KNOB: PART 03.812.004 (QTY. (B)(4))) IN THIS COMPLAINT RECORD SHOW NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW FOR THE INNER SHAFT (PART 03.812.003) WERE PERFORMED AS PART OF THIS INVESTIGATION. THE T-PAL SPACER APPLICATOR INNER SHAFT (03.812.003) IS UTILIZED IN THE T-PAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR) SYSTEM. AFTER TRIALING, THE APPLICATOR INNER SHAFT IS INSTALLED INTO THE APPLICATOR HANDLE (03.812.001) AND KNOB (03.812.004) 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 (PDL102). 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 DETACHED FROM THE IMPLANTED SPACER THE RETURNED INNER SHAFTS, KNOBS, AND APPLICATION HANDLES WERE EXAMINED AND THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED UPON EXAMINATION WHICH COULD HAVE POTENTIALLY CONTRIBUTED TO THE DESCRIBED COMPLAINT CONDITION. THE RETURNED INSTRUMENTS WERE TESTED AND WERE FOUND TO FUNCTION AS INTENDED. AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED AND NO OBJECTIVE EVIDENCE WAS DISCOVERED TO SUBSTANTIATE THE COMPLAINT CONDITION, THE COMPLAINT IS UNCONFIRMED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER, BASED ON THE FUNCTIONALITY OF THE RETURNED INSTRUMENTS; IT IS LIKELY THAT THE OBSERVED FAILURE WAS TECHNIQUE RELATED. 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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODE: LXH. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: THE LOT NUMBER IS 9831468 OR 9858948. DATE OF MANUFACTURE IS 4/12/16 FOR LOT NUMBER 9831468 AND 5/13/16 FOR LOT NUMBER 9858948. (B)(4). MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 12.APR.2016. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PART NUMBER 03.812.003 LOT NUMBER 9858948, T-PAL SPACER APPLICATOR INNER SHAFT MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13.MAY.2016. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THAT THE T-PAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SPACER SYSTEM) INSERTER WAS USED TO IMPLANT A PEEK (POLYETHERETHERKETONE) SPACER ON (B)(6) 2016. THE IMPLANT WAS PLACED INTO POSITION, THE KNOB WAS TURNED TO THE POSITION REQUIRED TO DETACH THE IMPLANT BUT THE IMPLANT WOULD NOT RELEASE FROM THE APPLICATOR SHAFT. THE APPLICATOR HANDLE WAS DISASSEMBLED FROM THE SHAFT AND IT WAS EASILY REMOVED FROM THE SPACER. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: T-PAL SPACER APPLICATOR HANDLE (PART 03.812.001, LOT UNKNOWN, QUANTITY 1), T-PAL SPACER APPLICATOR KNOB (PART 03.812.004, LOT UNKNOWN, QUANTITY 1), PEEK SPACER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317319 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PEEK SPACER