BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANI/ FLATOW HUMERAL HEAD CUTTING GUIDE

    MDR report key: 1910524 · Received November 18, 2010

    Report

    Report Number
    1822565-2010-01157
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN X-RAYING THE PT, IT WAS DISCOVERED THAT THE LOCKING SCREW WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/ FLATOW HUMERAL HEAD CUTTING GUIDE SHOULDER INSTRUMENT HSD ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention