BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L POLYETHYLENE INLAY

    MDR report key: 2192584 · Received July 1, 2011

    Report

    Report Number
    2530088-2011-00165
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST PRODISC-L IMPLANTATION, PRESENTED TO DOCTOR FOR EVAL OF POTENTIAL ALLERGY TO IMPLANT MATERIAL. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L POLYETHYLENE INLAY PRODISC-L IMPLANT MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPERIOR ENDPLATE| INFERIOR ENDPLATE