BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 806703 · Received January 3, 2007

    Report

    Report Number
    1526439-2007-00001
    Event Type
    Injury
    Date Received
    January 3, 2007
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED FDA OFFICE FOR ADDITIONAL INFO. THE REPORTING PERSON REQUESTED THAT THEIR CONTACT INFO NOT BE PROVIDED TO THE MFR AND AS A RESULT NO ADDITIONAL INFO IS KNOWN. BASED ON THE DATE OF IMPLANT, IT APPEARS THAT THE PT MAY HAVE BEEN PART OF THE CLINICAL TRIAL. DUE TO THE LIMITED INFO, IT COULD NOT BE DETERMINED IF THIS INFO HAS BEEN REPORTED TO DEPUY SPINE AS PART OF THE CLINICAL TRIAL OR AFTER AS AN ADVERSE OUTCOME. THE DEVICE IS NOT AVAILABLE FOR EVAL AND THE CATALOG AND LOT NUMBERS ARE NOT KNOWN AT THIS TIME. THE EVENT AS REPORTED CANNOT BE ATTRIBUTED TO THE DEVICE. INFO IS LIMITED AT THIS TIME AND NO CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 1

    RECEIVED A LETTER FROM FDA REPORTING AN ADVERSE OUTCOME TO A CHARITE DISC PT. REF. MW 1040887. PT REPORTS PAIN, POSSIBLE FACET FRACTURE, L5 VERTEBRAL FRACTURE. SUBSIDENCE AND POSTERIOR MIGRATION OF THE IMPLANT. IMPLANTING SURGEON HAS STATED THAT THERE IS "NOTHING WRONG WITH THE DISC" IMPLANTED.

    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 YR Required Intervention