BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 X 50 SCREW

    MDR report key: 2833172 · Received October 24, 2012

    Report

    Report Number
    2833172
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    June 11, 2009
    Report Date
    October 24, 2012
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AN X-RAY WAS READ THAT SHOWED A RETAINED FOREIGN BODY (RFB)IN THE SPINE. THE INVESTIGATION REVEALED IT WAS A PIECE OF A SCREW THAT WAS INSERTED THREE YEARS PREVIOUSLY. DECISION WAS MADE TO LEAVE PIECE IN PATIENT AS SURGEONS FELT IT WAS NOT HARMFUL TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20 X 50 SCREW ORTHOPEDIC SCREW HWC AESCULAP IMPLANT SYSTEMS, LLC * 51425463 51226058

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR