BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02364

    MDR report key: 3094045 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02364
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE VEPTR 2 WAS FOUND TO BE BROKEN. S HOOK OF VEPTR 2 GROWING ROD WAS CRACKED AND BROKEN AND WAS REMOVED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197311 MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention