BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 13.0MM

    MDR report key: 3241248 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04515
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTN
    PMA / PMN Number
    PREAM
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY SIX MONTHS AFTER SURGERY ON AN UNKNOWN DATE FOR THE FIXATION OF A FEMORAL NECK FRACTURE WITH THREE SCREWS AND TWO WASHERS, PATIENT DEVELOPED AN INFECTION OF THE LEFT HIP WHICH WAS DIAGNOSED ON AN UNKNOWN DATE. PATIENT UNDERWENT REMOVAL OF THE HARDWARE DUE TO THE INFECTION ON (B)(6) 2013. THE HARDWARE WAS REMOVED WITHOUT COMPLICATION. THIS REPORT IS FOR ONE WASHER 13.0MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340479 WASHER 13.0MM HTN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention