BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON® TT CURVED, INSERTER

    MDR report key: 5797048 · Received July 14, 2016

    Report

    Report Number
    3006340236-2016-00004
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 17, 2016
    Report Date
    February 14, 2018
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    LXH
    UDI-DI
    M682420010400
    PMA / PMN Number
    K083741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE SUBJECT DEVICE. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING MANUFACTURE OF THE SUBJECT DEVICE THAT WOULD CONTRIBUTE TO THIS FAILURE CONDITION. THE ENDOSKELETON TT IMPLANT CURVED INSERTER (P/N 4200-1040 LOT # Y140602) TIP WAS BROKEN OFF AND STUCK INSIDE OF THE ENDOSKELETON TT IMPLANT, LARGE 8MM (P/N 4114-3008 LOT # A150405). CAUSE UNKNOWN. ACTION LIMIT LIKELY EXCEEDED.

    Description of Event or Problem · 0

    IMPLANTING THE TT IMPLANT WITH A TT CURVED IMPLANT HOLDER, THE SURGEON WAS JUST PUSHING WITH HAND (NOT HAMMER) AND IN THE MOMENT OF THE PLACEMENT IN THE DISC, THE ANGLED IMPLANT INSERTER BROKE. THE INNER PART IN ONE SIDE AND THE OTHER PART AND THE IMPLANT IN OTHER SIDE. THE IMPLANT WAS ABLE TO BE RETRIEVED FROM THE DISC SPACE BY HOLDING THE SMALL EXTREME OF THE INNER PART THAT REMAINED. THE PROCEDURE WAS FINISHED USING ANOTHER TT IMPLANT AND THE TT STRAIGHT IMPLANT INSERTER. THE SURGERY TIME DID NOT SUFFER A BIG DELAY AND THE PATIENT IS OK.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE SUBJECT DEVICE. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING MANUFACTURE OF THE SUBJECT DEVICE THAT WOULD CONTRIBUTE TO THIS FAILURE CONDITION. THE ENDOSKELETON® TT IMPLANT CURVED, INSERTER'S (P/N 4200-1040, LOT Y140602) TIP WAS BROKEN OFF AND STUCK INSIDE OF THE ENDOSKELETON® TT IMPLANT, LARGE, 8MM (P/N 4114-3008, LOT A150405). THE INSTRUMENT WAS USED IN A MANOR NOT INTENDED AS IT WAS USED PAST THE MIDLINE AGAINST THE WARNING OR TECHNIQUE. THE ENDOSKELETON® TT SURGICAL TECHNIQUE WAS REVIEWED AND STATES "DETACH THE HOLDER ONCE THE TRAILING EDGE IS INSIDE THE DISC SPACE. PIVOT THE IMPLANT INTO ITS FINAL POSITION USING THE CURVED PUSHER. NOTE: ATTEMPTING TO PIVOT THE IMPLANT WITH THE IMPLANT HOLDER MAY DAMAGE THE INSTRUMENT." THE ENDOSKELETON® TT IMPLANT CURVED, INSERTER WAS USED TO POSITION THE IMPLANT IN THE DISC SPACE FURTHER THAN INTENDED. THIS CAUSED FORCE GREATER THAN INTENDED TO BE EXERTED ON THE INSERTER LEADING TO THE INSERTER'S TIP FAILURE.

    Description of Event or Problem · 1

    IMPLANTING THE TT IMPLANT WITH A TT CURVED IMPLANT HOLDER, THE SURGEON WAS JUST PUSHING WITH HAND (NOT HAMMER) AND IN THE MOMENT OF THE PLACEMENT IN THE DISC, THE ANGLED IMPLANT INSERTER BROKE. THE INNER PART IN ONE SIDE AND THE OTHER PART AND THE IMPLANT IN OTHER SIDE. THE IMPLANT WAS ABLE TO BE RETRIEVED FROM THE DISC SPACE BY HOLDING THE SMALL EXTREME OF THE INNER PART THAT REMAINED. THE PROCEDURE WAS FINISHED USING ANOTHER TT IMPLANT AND THE TT STRAIGHT IMPLANT INSERTER. THE SURGERY TIME DID NOT SUFFER A BIG DELAY AND THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449239 ENDOSKELETON® TT CURVED, INSERTER CURVED, INSERTER LXH TITAN SPINE, LLC 4200-1040 Y140602 M682420010400

    Patients

    Seq Age Sex Outcome Treatment
    1