BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2872360 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03903
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    Description of Event or Problem · 1

    PATIENT SUFFERED A PILON FRACTURE TO THE DISTAL TIBIA AND FIBULA ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2012. AT THIS TIME, PATIENT CAME INTO THE OR AND THE SURGEON PLACED AN EX-FIX ON THE TIBIA. ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2012, PATIENT RETURNED TO THE OR, AND WAS IMPLANTED WITH A SYNTHES MEDIAL DISTAL TIBIAL PLATE AND SCREW CONSTRUCT. THE EX-FIX WAS REMOVED. APPROXIMATELY THREE WEEKS POST-OPERATIVE, PATIENT RETURNED FOR A FOLLOW UP AND AN INFECTION WAS NOTICED AROUND THE TIBIAL PLATE INCISION SITE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND THE TIBIAL PLATE AND SCREWS WERE REMOVED. AT THIS TIME, THE FRACTURE WAS STABLE AND NO OTHER HARDWARE WAS NEEDED. PATIENT WAS SENT HOME IN A SPLINT AND RECEIVED ANTIBIOTICS. THIS IS 9 OF 10 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 60 YR Required Intervention LOCKING SCREW X 7, PLATE X 1, SCREW X 1