BEUDAMED
    FDA Adverse Event Other Summary report: N

    2-LEVEL PLATE/34MM

    MDR report key: 425170 · Received October 28, 2002

    Report

    Report Number
    425170
    Event Type
    Other
    Date Received
    October 28, 2002
    Date of Event
    August 19, 2002
    Report Date
    September 23, 2002
    Manufacturer
    STRYKER SPINE SA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT X-RAYS TAKEN 1 MONTH POST-OP SHOWED "MIGRATION OF THE INSTRUMENTATION." THE REPORT INDICATES THAT THE IMPLANTS WERE REMOVED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-LEVEL PLATE/34MM IMPLANT HRS STRYKER SPINE SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other