BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX TOP LOADING

    MDR report key: 2972420 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-10051
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD¿L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. LOT NUMBER PROVIDED IS INVALID. 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 THE TI MATRIX TOP LOADING POLYAXIAL HEAD HAD BROKEN THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69506 TI MATRIX TOP LOADING NKB SYNTHES BRANDYWINE 483340

    Patients

    Seq Age Sex Outcome Treatment
    1