BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2890472 · Received December 30, 2012

    Report

    Report Number
    2520274-2012-04383
    Event Type
    Injury
    Date Received
    December 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. DEVICE WAS IMPLANTED ON AN UNKNOWN DAY IN 1993.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL NAIL AND SCREW CONSTRUCT ON AN UNKNOWN DATE IN 1993. THIS PROCEDURE OCCURRED AT AN UNKNOWN HOSPITAL BY AN UNKNOWN SURGEON. ON AN UNKNOWN DATE, PATIENT BEGAN FEELING DISCOMFORT, AND EXAMINATION OF IMPLANT REVEALED THE TIBIAL NAIL WAS SITTING PROUD, BUT 2 DISTAL SCREWS WERE BROKEN. ON (B)(6) 2012, PATIENT RETURNED TO THE OR FOR REMOVAL OF HARDWARE. TIBIAL NAIL AND TWO DISTAL SCREW HEADS WERE REMOVED. THE TWO SCREW SHAFTS REMAINED IMPLANTED. IT IS REPORTED THAT THE PATIENT IS HEALED, NO ADDITIONAL HARDWARE WAS IMPLANTED, AND THE PATIENT IS RECOVERING WELL. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention TIBIAL NAIL, SCREW