BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2921184 · Received January 17, 2013

    Report

    Report Number
    2520274-2013-00366
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, 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. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2012 PATIENT WAS IMPLANTED WITH LCP CONDYLAR PLATE AND SCREW CONSTRUCT. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF DISTAL FEMUR HARDWARE DUE TO NON-UNION OF RIGHT FEMUR FRACTURE. INFECTION WAS DOCUMENTED ON INCISION. THE SURGEON REMOVED ALL HARDWARE; THE PATIENT WAS REVISED WITH EXTERNAL FIXATOR AND WITH ANTIBIOTIC CEMENT SPACER. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS IS 2 OF 15 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27123 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PLATE, SCREWS