BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 2063747 · Received April 14, 2011

    Report

    Report Number
    1526439-2011-00061
    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 L3-4 AND ALIF AT L5-S1. IMPLANT SIGNIFICANTLY TITLED AND ROTATED IMMEDIATELY POST-OP. IMPLANT WAS REMOVED 1-YEAR OUT WITH INTERBODY FUSION L3-4 WITH 14MM CAGE. TEN MM CAGE AT L4-5 AND HARDWARE L3-5. POST-OP HIP FLEXOR WEAKNESS AND L3 DYSESTHESIA THAT ALMOST COMPLETELY RESOLVED AFTER 3-MONTHS. DEVICE IS APPROVED FOR INSERTION AT L4-S1. IMPLANTATION OF THE DEVICE AT L3/L4 GOES AGAINST THE RECOMMENDATIONS MADE IN THE SURGICAL TECHNIQUE, THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH EACH DEVICE AS WELL AS THE INFORMATION PRESENTED AT THE TIME OF SURGEON TRAINING. NO DEFINITIVE CONCLUSIONS CAN BE MADE. AT THIS TIME, NO CONNECTION CAN BE MADE BETWEEN THE EVENT AND ANY SHORTCOMINGS OF THE DEVICE OR INFORMATION PROVIDED WITH 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 42 YR Required Intervention