BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ENDOPLATE, SIZE UNK

    MDR report key: 772885 · Received October 25, 2006

    Report

    Report Number
    1526439-2006-00231
    Event Type
    Injury
    Date Received
    October 25, 2006
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL AND THE LOT NUMBERS NOT KNOWN AT THIS TIME. LITTLE INFO IS KNOWN AT THIS TIME. 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.

    Description of Event or Problem · 1

    PT CONTACTED DEPUY SPINE INC. PT HAD GONE TO ANOTHER COUNTRY IN 2005 TO HAVE CHARITE ARTIFICIAL DISC IMPLANTED. INITIALLY HAD A GOOD OUTCOME. PT BEGAN TO DEVELOP A MILDER LEVEL OF PAIN. PT WENT TO A SURGEON IN THE US AND X-RAYS TAKEN SHOWED 2 - 2.5MM ANTERIOR MIGRATION OF THE SUPERIOR ENDPLATE. PT SENT THE X-RAY TO HER SURGEON IN ANOTHER COUNTRY. SHE TRAVELED BACK TO ANOTHER COUNTRY FOR REMOVAL OF CHARITE. AS SURGICAL INTERVENTION OCCURRED, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention SLIDING CORE: SIZE UNK| CHARITE ENDPLATE: SIZE UNK