BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUMANN TI ARTHR PLT PROX L RT

    MDR report key: 4645268 · Received March 20, 2015

    Report

    Report Number
    9613350-2015-00342
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE FOR REVIEW AND INVESTIGATION IS ONGOING. NO SOURCE DOCUMENTS WERE PROVIDED FOR REVIEW. A LOT NUMBER WAS RECEIVED FOR THE DEVICE. THE DEVICE HISTORY RECORDS WILL BE REVIEWED AS PART OF THE INVESTIGATION PROCESS. AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 LOTS OF NEUMANN TOTAL ARTHRODESIS PLATES HAVE BEEN MIXED (RIGHT AND LEFT). IT WAS REPORTED THAT THE LATERAL LASER MARKING IS WRONG. TWO NEUMANN TI ARTHR PLT PROX L RT PRODUCTS FROM THE SAME LOT WERE NOTIFIED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191906 NEUMANN TI ARTHR PLT PROX L RT NEUMANN TI ARTHR PLT PROX L RT HRS NORMED MEDIZIN-TECHNIK GMBH 9420/291C11

    Patients

    Seq Age Sex Outcome Treatment
    1