BEUDAMED
    FDA Adverse Event Summary report: N

    SUTURE ANCHOR

    MDR report key: 28988 · Received July 5, 1995

    Report

    Report Number
    28988
    Date Received
    July 5, 1995
    Date of Event
    February 9, 1995
    Report Date
    July 3, 1995
    Manufacturer
    ARTHROTEK INC.
    Product Code
    KGS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HARPOON SUTURE ANCHOR BROKE OFF IN PT'S SHOULDER. IT WAS REMOVED TOTALLY (ALL PIECES) BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR SUTURE ANCHOR KGS ARTHROTEK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *