BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM ROC EZ FASTENER

    MDR report key: 195850 · Received November 4, 1998

    Report

    Report Number
    1222933-1998-00003
    Event Type
    Injury
    Date Received
    November 4, 1998
    Date of Event
    September 2, 1998
    Report Date
    November 4, 1998
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPIC SHOULDER CASE CONVERTED TO AN OPEN PROCEDURE DUE TO AN ALLEGED ANCHOR FAILURE. NO CONSEQUENCE TO PT OR USER EXCEPT FOR THE CONVERSION FROM MINIMALLY INVASIVE TO OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.8MM ROC EZ FASTENER Implant SUTURE BONE ANCHOR MBI INNOVASIVE DEVICES, INC. NA 11255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention