BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUMANN TI ARTHR PLT PROX L LT

    MDR report key: 4645233 · Received March 20, 2015

    Report

    Report Number
    9613350-2015-00343
    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 MFR 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 INFO 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 TWO LOTS OF NEUMANN TOTAL ARTHRODESIS PLATES HAVE BEEN MIXED (RIGHT AND LEFT). IT WAS REPORTED THAT THE LATERAL LASER MARKING IS WRONG. THERE NEUMANN TI ARTHR PLT PROX L LT PRODUCTS FROM THE SAME LOT WERE NOTIFIED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191710 NEUMANN TI ARTHR PLT PROX L LT NEUMANN TI ARTHR PLT PROX L LT HRS NORMED MEDIZIN-TECHNIK GMBH 9421/291C11

    Patients

    Seq Age Sex Outcome Treatment
    1