BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01884

    MDR report key: 3042048 · Received April 9, 2013

    Report

    Report Number
    2520274-2013-01884
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH DISTAL TIBIA FRACTURE WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. NINE MONTHS POST-OPERATIVE, IT WAS NOTED THE PATIENT HAD AN ALLERGIC REACTION AND THE HEALING WAS NOT YET CONSOLIDATED. A DECISION FOR REOPERATION WAS MADE. PATIENT WAS RETURNED TO THE OR ON AN UNKNOWN DATE FOR IMPLANT REMOVAL. REPORTEDLY THE IMPLANT REMOVAL WAS SUCCESSFUL, HOWEVER, IT WAS NOTED THAT THE MOST PROXIMAL DLS WAS BROKEN AT THE BOTTOM. SURGEON PERFORMED REOSTEOSYNTHESIS AND REMOVAL OF NECROSIS. IT WAS ALSO REPORTED THE PATIENT HAD A WOUND INFECTION. AN ANALYSIS OF THE WOUND INFECTION WAS CONDUCTED AND REPORTEDLY THERE WAS AN ALLERGIC REACTION TO COBALT. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS 4 OF 8 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147045 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention