BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04482

    MDR report key: 3232852 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04482
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW. 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 RETURNED TO SURGEON ON AN UNKNOWN DATE, AND EXPRESSED THAT THE IMPLANTED HARDWARE WAS IRRITATING, AND THAT SHE WANTED IT REMOVED. UPON EXAMINATION SURGEON DETERMINED THAT THE FRACTURE WAS HEALED. THE SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2013 AND SUCCESSFULLY REMOVED THE HARDWARE. SURGEON IS OF OPINION THAT A POSITIVE OUTCOME WAS ACHIEVED AS THE PATIENT WAS HEALED. THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335086 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention