BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04020

    MDR report key: 3203766 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-04020
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 8 UNKNOWN SCREWS. DATE OF IMPLANT APPROXIMATELY (B)(6) 2012. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THIS REPORT IS FOR 8 UNKNOWN SCREWS. THE PATIENT WAS IMPLANTED WITH A 3.5MM LCP RECONSTRUCTION PLATE, A 3.5MM LCP T-PLATE AND EIGHT SCREWS APPROXIMATELY (B)(6) 2012 FOR A PILON FRACTURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED A NON-UNION. A SERIES OF FOLLOW UP X-RAYS WERE TAKEN ON UNKNOWN DATES THAT REVEALED A BROKEN RECONSTRUCTION PLATE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. ALL HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A DISTAL TIBIAL PLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303808 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention