BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 1003846 · Received February 14, 2008

    Report

    Report Number
    1526439-2008-00047
    Event Type
    Injury
    Date Received
    February 14, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    p040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFORMATION IS KNOWN AT THIS TIME. IF ADDITIONAL INFO IS REPORTED THIS COMPLAINT FILE SHALL BE UPDATED. NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. AT THIS TIME NO CONNECTION CAN BE MADE BETWEEN THE EVENT AND ANY SHORTCOMINGS OF THE DEVICE OR INFO PROVIDED WITH THE DEVICE. [SEE SCANNED PAGES].

    Description of Event or Problem · 1

    PATIENT REPORTED IMPLANT OF A CHARITE ARTIFICIAL DISC AT L4/5 IN 2006. SLIGHT RELIEF FOR A FEW MONTHS THAN PAIN WORSENED. BASED ON THE INFO REPORT IT APPEARS THAT THE DEVICE HAS SUBSIDED. PATIENT IS SEEING A SPEICALIST TO DISCUSS A POSSIBLE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE ARTIFICIAL DISC, SIZE UNK ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention