BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL PROTI 360

    MDR report key: 10784610 · Received November 4, 2020

    Report

    Report Number
    3012966183-2020-00006
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 2, 2020
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021653
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER IS UNABLE TO RETURN DEVICE AT THIS TIME DUE TO COVID-19 RESTRICTIONS. HOWEVER, THE CUSTOMER PROVIDED THE RESULTS OF THEIR INVESTIGATION OF THE COMPLAINT DEVICE. A VISUAL AND FUNCTIONAL INVESTIGATION DID NOT DETECT ANY MAJOR ISSUES WITH THE RETURNED ITEMS. THERE IS NORMAL WEAR AND TEAR AND THE DEVICES COULD BE USED AS INTENDED. THE COMPLAINT NOTED THAT THE SURGEON "HAMMERED HARDLY WITH MALLET". THE SURGICAL TECHNIQUE STATES THAT HAMMERING SHOULD BE "CONTROLLED AND LIGHT". THE NEED OF HARD HAMMERING TO INSERT AND TURN THE CAGE IS UNUSUAL AND SHOULD BE AVOIDED. HARD HAMMERING CAN POTENTIALLY LEAD TO A SITUATION WHERE THE CAGE BREAKS THROUGH THE ANTERIOR WALL. A REVIEW OF THE X-RAYS ALSO SHOWED THAT THE IMPLANT WAS ALREADY OVER-PIVOTED. IN THIS SITUATION IT CAN POTENTIALLY HAPPEN THAT THE CAGE DISENGAGES FROM THE APPLICATOR AS DESCRIBED IN THE COMPLAINT. INSUFFICIENTLY REMOVED DISC MATERIAL MIGHT BE THE CAUSE OF THE DESCRIBED ISSUES. THE INVESTIGATION DID NOT DISCOVER ANY ISSUES RELATED TO INSTRUMENTS OR IMPLANT. NO CAPA AND NO TRENDS HAVE BEEN IDENTIFIED. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF INVESTIGATION, THERE WAS NO CAPA AND NO TRENDS ASSOCIATED WITH THIS EVENT TYPE. THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION, AND THEREFORE, THE INVESTIGATION IS STILL PENDING. A REVIEW OF THE LOT WAS CONDUCTED AND FOUND NO NON-CONFORMANCE ASSOCIATED WITH THIS SPECIFIC COMPLAINT TYPE. THE LOT MET RELEASE REQUIREMENTS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    "FOR THE CASE ON (B)(6) 2020, A 10MM PROTI CAGE (108812010 LOT) NEEDED TO BE CONDEMNED AS THE CAGE DISENGAGED FROM THE ADVANCED APPLICATOR. PARTS OF THE ADVANCED APPLICATOR ARE LISTED AS FOLLOWS, ADVANCED APPLICATOR INNER SHAFT (03.812.521) + ADVANCED APPLICATOR OUTER SHAFT (03.812.520)+ APPLICATOR KNOB (03.812.004). THE SURGEON USED APPLICATOR FOR 10 MM TRIAL IN L5-S1, THE APPLICATOR KNOB COULDN'T BE TURNED AND COMPLAINED THE APPLICATOR END WAS TOO BULKY AND REQUESTED TO CHANGE TO ADVANCED APPLICATOR FOR 10MM TRIAL AND THE IMPLANT. A GREAT RESISTANCE WAS ENCOUNTERED WHEN THE 10MM PROTI CAGE WAS BEING INSERTED. LITTLE PROGRESS WAS OBSERVED EVEN SURGEON HAMMERED HARDLY WITH MALLET. THEN THE SURGEON TURNED THE APPLICATOR KNOB TO AN OPEN POSITION FOR THE IMPLANT TO TURN. SURGEON THEN HAMMERED AGAIN TO TURN THE PROTI CAGE. THE CAGE STARTED TO TURN AS SHOWN IN XRAY, SURGEON HAMMERED HARDLY SEVERAL TIMES IN ORDER TO FULLY TURN THE CAGE. SUDDENLY, THE CAGE BROKE THROUGH THE ANTERIOR ANNULUS AND WENT ANTERIORLY. SURGEON GRABBED THE ADVANCED APPLICATOR AND FOUND THAT IT HAS ALREADY DETACHED FROM THE CAGE. REMOVAL TOOL WAS ATTEMPT TO GRAB THE IMPLANT, YET, IT WAS LOCATED TOO ANTERIORLY WHICH REMOVAL TOOLS COULDN'T REACH. THE DISENGAGED IMPLANT WAS REMOVED THROUGH ANOTHER INCISION FROM ANTERIOR APPROACH. SYNFIX EVOLUTION WAS USED TO FUSE L5-S1. SURGEON WOULD LIKE US TO INVESTIGATE WHY THE CAGE DISENGAGED FROM THE ADVANCED APPLICATOR. THIS COMPLAINT INVOLVES ONE (1) DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253075 T-PAL PROTI 360 INTERBODY SPACER SYSTEM MAX TYBER MEDICAL 108812010 112213 00819917021653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention