BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2885144 · Received December 26, 2012

    Report

    Report Number
    2520274-2012-04326
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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 TIBIAL NAIL-EX, ONE-THIRD TUBULAR PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. ON AN UNKNOWN DATE, PATIENT REPORTED PAIN FROM THE IMPLANTED HARDWARE. PATIENT RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. ALL HARDWARE WAS REMOVED ON THIS DATE, AND IT WAS REPORTED THAT THE FRACTURE WAS HEALED AND NO OTHER DEVICES WERE IMPLANTED. THIS IS 11 OF 17 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 47 YR Required Intervention TIBIAL NAIL, PLATE, SCREWS