BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2822874 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02991
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    PATIENT WAS IMPLANTED WITH TIBIA PLATE AND SEVEN SCREWS ON AN UNKNOWN DATE. PATIENT PRESENTED TO THE SURGEON ON AN UNKNOWN DATE COMPLAINING OF PAIN. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. IT IS REPORTED PATIENTS PILON BONE FRACTURE WAS COMPLETELY HEALED. THIS IS 8 OF 8 REPORTS FOR THE SAME 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 PLATE, SCREWS