BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW LOCKING

    MDR report key: 2971309 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01099
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH VA LCP PLATE AND SCREWS. DURING A FOLLOW UP VISIT, DATE UNKNOWN, THE SURGEON NOTED THAT THE WOUND HAD BROKEN DOWN, LOOKED RED AND THE PLATE WAS SHOWING. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2013, HARDWARE WAS REMOVED. SURGEON INITIALLY THOUGHT THERE WAS AN INFECTION, HOWEVER, WHEN HE OPENED THE INCISION THERE WAS NO INFECTION DETECTED. THE SURGEON WAS HAPPY WITH HOW THE WOUND LOOKED AND PERFORMED AN I & D PROCEDURE. THE HARDWARE WAS NOT REPLACED AND THE SURGERY WENT FINE. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL FACILITY. THIS IS 2 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76708 SCREW LOCKING HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention