BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01870

    MDR report key: 3041743 · Received April 8, 2013

    Report

    Report Number
    2520274-2013-01870
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 WAS IMPLANTED WITH 12 HOLE LCP PLATE AND SCREW CONSTRUCT ON (B)(6) 2013 FOR A FRACTURED HUMERUS. POST-OPERATIVE FOLLOW UP DETERMINED THAT THE FRACTURE WAS FAILING. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH OTHER SYNTHES HARDWARE. THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW. THIS IS 8 OF 11 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143494 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention