BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITI 44 PEGGED GLENOID

    MDR report key: 3932076 · Received June 20, 2014

    Report

    Report Number
    3004983210-2014-00015
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    February 22, 2012
    Report Date
    June 10, 2014
    Manufacturer
    TORNIER INC.
    Product Code
    HSD
    PMA / PMN Number
    K060988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    LOOSE GLENOID AND LOW GRADE INFECTION REQUIRED GLENOID REMOVAL. RIGHT SHOULDER. IMPLANTED (B)(6) 2011; ONSET DATE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362417 AFFINITI 44 PEGGED GLENOID NONE HSD TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention