BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-KNOT SUTURE CLIP

    MDR report key: 207194 · Received January 19, 1999

    Report

    Report Number
    1222933-1999-00001
    Event Type
    Injury
    Date Received
    January 19, 1999
    Date of Event
    December 14, 1998
    Report Date
    January 19, 1999
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC BARKART PROCEDURE, A Y-KNOT DEVICE DID NOT FUNCTION PROPERLY. DUE TO THE AMOUNT OF TIME IT TOOK TO REMOVE THE IMPLANT, THE DR DECIDED TO OPEN THE PT TO FINISH THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-KNOT SUTURE CLIP Implant SUTURE CLIP FZP INNOVASIVE DEVICES, INC. NA 11550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention