BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 9835069 · Received March 16, 2020

    Report

    Report Number
    2027467-2020-00018
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXX
    UDI-DI
    00840967192673
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED INNER SHAFT CONFIRMED THAT THE DISTAL THREADED TIP HAD FRACTURED AND SEPARATED FROM THE INSTRUMENT. THE DETACHED SECTION WHICH REMAINS IMPLANTED WITHIN THE C5 SCREW IS APPROXIMATELY .125" IN-LENGTH. IN ADDITION TO THE INNER SHAFT, THERE WAS ALSO A TOTAL OF THREE SEPARATE HEXALOBE SCREW REMOVAL TOOLS USED IN CONJUNCTION WHICH ALSO BROKE DURING THE CASE. IT IS UNKNOWN WHICH OUTER SHAFT FRAGMENT ALSO REMAINS WITHIN THE SCREW. 713-0001, LOT 812100R1 MFG'D OCT-2019, 71731-01, LOT 6630201 MFG'D NOV-2017, 71731-01, LOT 8063701 MFG'D MAY-2012. ALL THE REMAINING DISTAL TIPS OF ALL THREE SCREW REMOVAL TOOLS APPEAR TO HAVE BEEN BENT/TWISTED IN A CLOCKWISE DIRECTION WHICH IS ASSOCIATED WITH TIGHTENING. THESE INSTRUMENT ARE INTENDED TO BE USED FOR SCREW REMOVAL. ADDITIONALLY, THE DETACHED SECTIONS OF ALL THE INSTRUMENTS UTILIZED IN THE CASE ARE MANUFACTURED OUT OF 465SS (STAINLESS STEEL) AND CERTIFIED TO ASTM A564-13.

    Description of Event or Problem · 1

    DURING AN ACDF CASE OF THE C4-C7, THE SURGEON WAS INSERTING SCREWS USING THE SCREW REMOVER TOOL AND THE DISTAL TIPS FRACTURED AND BROKE. THE TIPS OF BOTH THE OUTER AND INNER SHAFTS REMAIN WITHIN THE SCREW HEAD POSITIONED WITHIN THE RIGHT C5 VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299094 TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM HXX HXX ALPHATEC SPINE INC 71731-02 7528301 00840967192673

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other