BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 2063720 · Received April 14, 2011

    Report

    Report Number
    1526439-2011-00060
    Event Type
    Injury
    Date Received
    April 14, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD 2-LEVEL TDR AT L4-5 AND AT L5-S1. THEN EXPERIENCED PROGRESSIVE SCOLIOSIS WITH BACK AND LEG PAIN 1-YEAR OUT. CHARITE WAS REMOVED AND PATIENT HAD 1-LEVEL POSTERIOR FUSION AT L4-5 WITH INTERBODY CAGE. SCOLI CORRECTED FROM 47-DEGREE TO 25-DEGREE WITH SIGNIFICANT IMPROVEMENT OF PAIN. USING TWO CHARITE IMPLANTS IN ONE PATIENT IS AN OFF LABEL USE. CHARITE IS APPROVED FOR USE AS A ONE LEVEL IMPLANT ONLY. SURGEON IMPLANTED TWO DISCS. THIS GOES AGAINST THE INFORMATION THAT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH EACH DEVICE. NO CONCLUSION CAN BE MADE. 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 DISK MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention