BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX PEEK ORTHOCORD

    MDR report key: 2850030 · Received November 16, 2012

    Report

    Report Number
    2850030
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEPUY ARTHROSCOPIC 4.5MM ANCHOR FAILED TO FUNCTION CORRECTLY WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALIX PEEK ORTHOCORD SCREW, FIXATION, BONE HWC DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 4.5MM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR