BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2830990 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03122
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    FACILITY REPORTS PATIENT WAS IMPLANTED WITH LCP CONDYLAR PLATE ON (B)(6) 2012 FOR ORIF OF LEFT FEMUR FRACTURE. PATIENT PRESENTED TO SURGEON ON (B)(6) 2012 WITH INFECTION AT IMPLANT SITE AND WAS READMITTED TO FACILITY FOR ANTIBIOTIC THERAPY. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 WHERE WOUND WAS CLEANED AND WOUND VAC WAS ATTACHED. PATIENT HAS BEEN THROUGH IRRIGATION AND DRAINAGE,IND, PROCEDURE SEVERAL TIMES. FACILITY CONTACT BELIEVES PLATE AND SCREWS REMAIN IMPLANTED, ALSO BELIEVES PATIENT IS STILL IN HOUSE FOR ANTIBIOTIC THERAPY. THIS IS 5 OF 9 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention PLATE, SCREWS