BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFIX

    MDR report key: 89109 · Received May 1, 1997

    Report

    Report Number
    1223420-1997-90001
    Event Type
    Malfunction
    Date Received
    May 1, 1997
    Report Date
    April 24, 1997
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED A MODIFIED BANKART 8 MONTHS AGO. THE PT RECENTLY COMPLAINED OF SORENESS. UPON EXAM, THE DR FOUND THAT THE ANCHOR HAD MIGRATED DOWN HIS ARM. THE ACHOR WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFIX SUTURE ANCHOR HWC LI MEDICAL TECHNOLOGIES, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention