BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE #1 2.8MM ROC FASTENER X 2 UNITS

    MDR report key: 88682 · Received May 1, 1997

    Report

    Report Number
    88682
    Event Type
    Injury
    Date Received
    May 1, 1997
    Date of Event
    March 21, 1997
    Report Date
    April 11, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED DURING AN ARTHROSCOPIC BANKART PROCEDURE. THREE CONSECUTIVE ANCHORS BROKE. THE DR DECIDED TO OPEN THE PT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1 2.8MM ROC FASTENER X 2 UNITS Implant BONE ANCHOR MBI INNOVASIVE DEVICES, INC. NA 10547
    2 DEVICE #2 3.5MM ROC FASTENER Implant BONE FASTENER KGS INNOVASIVE DEVICES, INC. NA 10505

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention