BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM

    MDR report key: 2445574 · Received February 6, 2012

    Report

    Report Number
    9617544-2012-00032
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PRODUCTS RETURNED WITH THIS COMPLIANT INCLUDE: CAT #48811234 AVIATOR ASSY TWO LEVEL PLATE SIZE 34, LOT 119014. CAT# 48824012 AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM, LOT 2WF. METHOD - COMPLAINT HISTORY ANALYSIS, DHR REVIEW, VISUAL INSPECTION, X-RAY REVIEW, RISK ASSESSMENT. RESULTS - THIS IS THE FIRST COMPLIANT RECEIVED RELATED TO POST-OP BACK-OUT OF AN AVIATOR PLATE. THE DHR OF ALL THE RETURNED PRODUCT WAS REVIEWED AND NO DEVIATIONS WERE NOTED. ALL THE RETURNED PRODUCTS WERE VISUALLY INSPECTED AND THE PLATE SHOWED SIGNS OF MECHANICAL WEAR. ONE OF THE SPRING-BARS WAS MISSING; HOWEVER, THE POST-OP X-RAY SHOWED THAT ALL THE SCREWS WERE FULLY SEATED BENEATH THE SPRING-BARS. THE SALES REP WAS ABLE TO CONFIRM THAT THE BAR BROKE DURING EXPLANATION OF THE DEVICE. THE RETURNED SCREWS SHOWED SIGNS OF MECHANICAL WEAR. SINCE THE SCREWS BACKED OUT OF THE VERTEBRAL BODY A REVISION SURGERY WAS PERFORMED AND THE HARDWARE WAS NOT REPLACED. CONCLUSION: POOR BONE QUALITY, TRAUMA OR EXTREME DEFORMITY OF THE CERVICAL SPINE COULD HAVE LEAD TO THE SCREWS BACKING OUT. ALSO, AN INCORRECTLY CONTOURED PLATE COULD HAVE ALSO LEAD TO THE SCREWS BACKING OUT.

    Description of Event or Problem · 1

    AS REPORTED "AS SEEN ON FILM, THE 2 CEPHALAD SCREWS HAVE BOTH BACKED OUT OF THE VERTEBRAL BODY, BUT STAYED IN THE PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA 3L5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R