BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM HEMI SPOOL

    MDR report key: 3161776 · Received June 6, 2013

    Report

    Report Number
    3004983210-2013-00016
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    TORNIER INC
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    PT HAD A HEMI ARTHROPLASTY ON ELBOW ONE YEAR AGO USING LATITUDE. PT WAS COMPLAINING OF PAIN AT FULL EXTENSION. DOCTOR FELT CONVERTING TO A TOTAL WOULD ALLEVIATE FURTHER COMPLAINTS FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251383 CUSTOM HEMI SPOOL NONE HSD TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention