BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM/18CM ROC FASTENER WITH THREADER

    MDR report key: 89733 · Received May 9, 1997

    Report

    Report Number
    1222933-1997-00004
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    April 8, 1997
    Report Date
    May 6, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE ON A BONE ANCHOR BECAME UNTHREADED. DR DECIDED TO OPEN THE PT TO REPLACED THE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.8MM/18CM ROC FASTENER WITH THREADER Implant BONE ANCHOR MBI INNOVASIVE DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention