BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0 VARIABLE ANGLE SELF-DRILLING SCREW, 16MM (TI 6AL 4V ELI)

    MDR report key: 3875378 · Received June 16, 2014

    Report

    Report Number
    2027467-2014-00016
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    September 26, 2013
    Report Date
    June 13, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION CANNOT BE CONDUCTED. THE SUSPECT DEVICE HAS NOT BEEN RETURNED NOR HAS THE IDENTIFYING LOT NUMBER BEEN PROVIDED. THE TRESTLE ANTERIOR CERVICAL PLATING SYSTEM IS A TEMPORARY DEVICE USED TO STABILIZE THE CERVICAL SPINE DURING BONE FUSION DEVELOPMENT. IT IS INTENDED FOR USE IN THE ANTERIOR CERVICAL SPINE (C2-C7). A PRIMARY FEATURE OF THE TRESTLE PLATING SYSTEM IS THE PROPRIETARY ZERO STEP SELF-LOCKING MECHANISM. WHILE ADVANCING THE SCREW, THE BLOCKING SLIDE WILL MOVE MEDIALLY. WHEN THE SCREW IS FULLY INSERTED AND THE SCREWDRIVER REMOVED, THE BLOCKING SLIDE WILL RETURN TO THE CENTER POSITION. BOTH THE SURGICAL TECHNIQUE AND INSTRUCTION FOR USE (INS-014) STATE; THE SURGEON MUST TAKE GREAT CARE TO PROPERLY POSITION BONE SCREW HOLES WHEN USING THE VARIABLE DRILL GUIDE AND SELF CENTERING AWL. EXCESSIVELY CONVERGING HOLE PATTERNS MAY PROHIBIT PROPER SEATING OF THE BONE SCREWS. HOLE PATTERNS ANGLED BEYOND 9° MAY PROHIBIT PROPER SEATING.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT REVISION SURGERY ON 9/26/13 TO REMOVE A THREE LEVEL TRESTLE PLATING SYSTEM. IT WAS REPORTED THAT THE 16MM SCREW LOCATED IN THE RIGHT SIDE OF THE C7 HAD BECAME DETACHED FROM THE PLATES LOCKING MECHANISM AND HAD MIGRATED APPROXIMATELY 9MM. THE SYSTEM ORIGINALLY IMPLANTED IN (B)(6) 2009 WAS NOT REPLACED AS THE SURGEON FOUND FUSION HAD OCCURRED AT ALL THREE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352645 4.0 VARIABLE ANGLE SELF-DRILLING SCREW, 16MM (TI 6AL 4V ELI) KWQ KWQ ALPHATEC SPINE INC 61240-016

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention