BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINS/WIRES

    MDR report key: 2603458 · Received June 4, 2012

    Report

    Report Number
    2520274-2012-00974
    Event Type
    Injury
    Date Received
    June 4, 2012
    Report Date
    October 1, 2010
    Product Code
    DZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    THE MANAGER, MARKET DEVELOPMENT, TRAUMA REPORTED SURGEON SUBMITTED A PRESENTATION, "NONUNION" FAILURE OF A FRACTURE TO HEAL, FAILURE OF ADVANCING HEALING FOR APPROVAL. IT SHOWCASES TEN PATIENTS, VARIOUS COLLECTED CASES ON THE TOPIC OF NONUNIONS. PATIENT #9: A FEMALE PATIENT EXPERIENCED A LEFT FEMUR FRACTURE AND WAS IMPLANTED WITH AN ANGLED BLADE PLATE AND SCREWS ON AN UNKNOWN DATE. X-RAYS ON (B)(6) 2004 SHOWED AN NON-UNION AND THREE (3) SCREWS PULLED OUT. PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNKNOWN DATE AND THE 3 SCREWS WERE REMOVED AND SURGEON USED CERCLAGE WIRE TO HOLD THE PLATE. EVENTUALLY THE ENTIRE CONSTRUCT WAS REMOVED, UNKNOWN DATE, AND THE PATIENT WAS REVISED TO A STRAIGHT PLATE. IT CAN NOT BE VERIFIED IF THE PRODUCT IS SYNTHES PRODUCT. THIS IS 5 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINS/WIRES DZK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE| SCREW| WIRE