BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE SIZE 3 ENDPLATE, 0-DEGREE

    MDR report key: 2013248 · Received March 8, 2011

    Report

    Report Number
    1526439-2011-00036
    Event Type
    Injury
    Date Received
    March 8, 2011
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS IMPLANTED AT L5/S1 AND REPORTED HAVING A GOOD OUTCOME. THE CAUSE OF THE PAIN WHICH BEGAN 3-YEARS POST OP IS NOT KNOWN AT THIS TIME. RECOMMENDED THAT THE PT DISCUSS THIS DIRECTLY WITH A MEDICAL PROFESSIONAL. NO DEFINITIVE CONCLUSIONS CAN BE MADE. 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

    CHARITE PT CONTACTED DEPUY SPINE REPORTING THAT HE IS EXPERIENCING BACK / LEG PAIN. HE WAS IMPLANTED DURING THE TRIAL (B)(6) 2001. HE DID WELL FOR THE FIRST THREE YEARS BUT THEN BEGAN TO EXPERIENCE BACK AND LEG PAIN. HIS PAIN HAS INCREASED OVER TIME AND HE IS INVOLVED IN PAIN MANAGEMENT PROGRAM. CAUSE OF THE PAIN CANNOT BE DETERMINED HOWEVER, AS AN ADVERSE OUTCOME WAS REPORTED AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE SIZE 3 ENDPLATE, 0-DEGREE ARTIFICIAL DISC IMPLANT MJO DEPUY SPINE INC. NA WL001017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CORE: 75641213, LOT: WL0023136| ENDPLATE: 75640013, LOT: WL01010