BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHREX, INC.

    MDR report key: 399670 · Received June 12, 2002

    Report

    Report Number
    1220287-2002-00002
    Event Type
    Other
    Date Received
    June 12, 2002
    Date of Event
    March 5, 2002
    Report Date
    June 12, 2002
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTS WITH PAIN IN THE OSTEOTOMY SITE. THE OSTEOTOMY PLATE WAS EXPLANTED. IT WAS BROKEN INTO 3 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX, INC. OSTEOTOMY PLATE HRS ARTHREX, INC. AR-13200-10.0 679010906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other