BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE

    MDR report key: 3790147 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11223
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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

    THE SYNTHES COMPLAINT HANDLING UNIT RECEIVED A MAUDE EVENT REPORT NUMBERED (B)(4) VIA STANDARD MAIL ON 4/07/2014. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267071 GUIDE FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1