BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2872608 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03962
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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

    SYNTHES WAS NOTIFIED: PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH 2 PLATES AND SCREWS. IT WAS DISCOVERED ON AN UNKNOWN DATE THE PLATE WAS BROKEN AND PATIENT HAD A NONUNION. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, FOR HARDWARE REMOVAL. PATIENT HAD ELEVATED INFECTION LEVELS, PATIENT WAS NOT REVISED TO NEW HARDWARE; RUNNING TESTS FOR THE INFECTION, NO HARDWARE WILL BE RETURNED. THIS IS 12 OF 26 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention PLATES, SCREWS