BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    MDR report key: 6035216 · Received October 17, 2016

    Report

    Report Number
    0009617544-2016-00419
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 22, 2016
    Report Date
    January 16, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. CATALOG# 48811228, PMA#: K083562. METHOD: RISK ASSESSMENT, RESULT: MANUFACTURING FILES COULD NOT BE REVIEWED DUE TO LACK OF PARTS. THE PARTS WERE NOT RETURNED. CONCLUSION: THE ROOT CAUSE IS NOT DETERMINED DUE TO LACK OF INFORMATION AND RETURNED PARTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: LOCKING PLATE BROKE AND 2 SCREWS BACKED OUT. WE EXPLANTED THE 2 SCREWS AND A PIECE OF THE BROKEN LOCKING PLATE (BEING STERILIZED NOW). HE ALSO FUSED FROM BEHIND BECAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: LOCKING PLATE BROKE AND 2 SCREWS BACKED OUT. WE EXPLANTED THE 2 SCREWS AND A PIECE OF THE BROKEN LOCKING PLATE(BEING STERILIZED NOW). HE ALSO FUSED FROM BEHIND BECAUSE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684221 AVIATOR ASSY TWO LEVEL PLATE SIZE 28 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. KWQ STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention