BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM ROC FASTENER

    MDR report key: 61806 · Received January 8, 1997

    Report

    Report Number
    1222933-1997-00001
    Event Type
    Injury
    Date Received
    January 8, 1997
    Date of Event
    December 11, 1996
    Report Date
    January 6, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A BANKHART PROCEDURE, AN ANCHOR WAS DEPLOYED AND DID NOT APPEAR TO BE FULLY SEATED. UPON TYING THE SUTURE, THE ANCHOR BROKE. THE DR DECIDED TO OPEN THE PT AND TUNNEL TO COMPLETE THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention
    2