BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2854590 · Received December 3, 2012

    Report

    Report Number
    2520274-2012-03506
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. IMPLANTED APPROXIMATELY 9 MONTHS, (B)(6) 2012, OR 10 MONTHS, (B)(6) 2011, AGO. 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 APPROXIMATELY 9 MONTHS, (B)(6) 2012, OR 10 MONTHS, (B)(6) 2011 AGO WITH PLATES AND SCREWS FOR A FOOT FUSION. IT WAS DETERMINED THE PATIENT DEVELOPED AN INFECTION, DATE UNKNOWN. SURGEON RETURNED THE PATIENT TO THE O.R. ON (B)(6) 2012; HARDWARE WAS REMOVED AND THE WOUND WAS CLEANED AND TREATED FOR INFECTION. SURGEON DID NOT REVISE THE PATIENT TO ANY NEW HARDWARE. HOSPITAL WILL NOT BE RETURNING THE PARTS. THIS IS 19 OF 19 REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATES, SCREWS