BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE ROD

    MDR report key: 359430 · Received November 2, 2001

    Report

    Report Number
    8010177-2001-00003
    Event Type
    Injury
    Date Received
    November 2, 2001
    Date of Event
    May 25, 2001
    Report Date
    May 28, 2001
    Manufacturer
    STRYKER LEIBINGER
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE GENIOGLOSSUS MUSCLE ADVANCEMENT PROCEDURE, THE MUSCLE WAS ALVUSED FROM THE BONE AS A RESULT OF THE GUIDE ROD INSTRUMENTATION BREAKING DURING THE OSTEOTOMY PORTION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49340 GUIDE ROD GUIDE ROD / PLATE LXH STRYKER LEIBINGER 62-25025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR