BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 2063721 · Received April 14, 2011

    Report

    Report Number
    1526439-2011-00059
    Event Type
    Injury
    Date Received
    April 14, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD TDR AT L4-5 AND ALIF AT L5-S1. FIVE MONTHS OUT, HAD FRACTURE OF L4-5 WITH SPONDYLOLISTHESIS. PERFORMED INTERBODY FUSION CAGE, LATERAL PLATES AND SCREWS. POST-OP, EXPERIENCED PARESTHESIA WITH HIP FLEXOR WEAKNESS THAT RESOLVED 6-MONTHS OUT. LITTLE INFORMATION IS KNOWN AT THIS TIME. AT THIS TIME, NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND ANY SHORTCOMING OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A PAPER WAS RECENTLY PUBLISHED (SPINE VOL. 14 (B)(6) 2011) DISCUSSED REMOVAL OF THE (CHARITE) ARTIFICIAL DISC. FOUR CASES WERE DOCUMENTED. THE SPECIFIC INFORMATION WAS VERY LIMITED AND IT COULD NOT BE DETERMINED IF THESE CASES HAVE BEEN PREVIOUSLY REPORTED TO DEPUY SPINE. AS A RESULT FOR COMPLAINTS WERE ENTERED INTO OUR DATABASE AND MDR FILED TO DOCUMENT THESE EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention