BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE, HEXALOBE SCREW (TI-6AI-4V ELI)

    MDR report key: 8727623 · Received June 24, 2019

    Report

    Report Number
    2027467-2019-00031
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 14 SCREWS CONTAINING TWO (2) SEPARATE DESCRIPTIONS/PART NUMBERS & THREE (3) UNIQUE IDENTIFYING LOT NUMBERS WERE UTILIZED DURING THE CASE. IT IS UNKNOWN WHICH BELONGS TO THE SCREW WHICH PASS THRU THE PLATE. 71240-14; 4.0MM VARIABLE ANGLE, SELF-DRILLING HEXALOBE SCREW, 14MM - LOT# 8275106 - MFG'D 4/11/19. 71240-14; 4.0MM VARIABLE ANGLE, SELF-DRILLING HEXALOBE SCREW, 14MM - LOT# 8275107 - MFG'D 5/2/19. 71345-14; 4.5MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM - LOT# 8275124 - MFG'D 3-27-19. REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL THREE (3) MANUFACTURED LOTS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE TRESTLE LUXE SCREWS WERE FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. PREVIOUS ENGINEERING INVESTIGATION DETERMINED THAT THIS TYPE OF OCCURRENCE IS THE RESULTS OF OVER ANGULATION OF THE ANCHORING PLATE SCREW. BOTH THE SURGICAL TECHNIQUE (LIT-84315) AND INSTRUCTIONS FOR USE (INS-048) 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

    DURING A 4-LEVEL CASE, WHILE PLACING THE PLATE ON THE MIDDLE SEGMENT OF THE VERTEBRAL BODY, THE SCREW WENT THROUGH THE PLATE. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522952 VARIABLE ANGLE, HEXALOBE SCREW (TI-6AI-4V ELI) SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization