BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 2113423 · Received May 31, 2011

    Report

    Report Number
    1526439-2011-00087
    Event Type
    Injury
    Date Received
    May 31, 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
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF MEDICAL RECORDS REVIEW. PRE-OP: ON (B)(6) 2005, X-RAYS/MRI SHOW HNP WITH DEGENERATIVE DISC DISEASE AT L5-S1. CHARITE DISC IMPLANTED ON (B)(6) 2005 AT L5-S1. POST-OP: ON (B)(6) 2005, X-RAYS SHOW DISC IN GOOD POSITION WITH NO MIGRATION OR SUBSIDENCE. ON (B)(6) 2005, BACK PAIN IS REPORTED. ON (B)(6) 2005, BACK PAIN REPORTED. ON (B)(6) 2005, BACK/LEG PAIN REPORTED. X-RAYS SHOW DISC IN GOOD POSITION, LOOKED AT MRI FROM (B)(6) 2005 WHICH SHOWED SEVERE DEGENERATION L5-S1 WITH HNP BUT ALSO DISC BULGE AT L5-S1. ON (B)(6) 2006, BACK PAIN WITH DISCOGRAPHY CONCORDANT PAIN L4-L5. X-RAYS AGAIN SHOW DISC IN GOOD POSITION. 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

    FOLLOWING THE PROCESS OF LEGAL DISCOVERY, MEDICAL RECORDS WERE RECENTLY MADE AVAILABLE TO DEPUY SPINE FOR REVIEW. THE ASSOCIATED MEDICAL RECORDS FOR THIS PT WERE REVIEWED AND IT WAS DETERMINED THAT THERE WAS NO CORRESPONDING COMPLAINT FILE. IT APPEARS THAT AT THE TIME OF LEGAL NOTIFICATION, THIS INFO WAS NOT REPORTED TO THE REGULATORY COMPLIANCE DEPT. AS A RESULT, A REPORT IS BEING OPENED NOW TO DOCUMENT THIS EVENT. 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 ARTIFICIAL DISC, SIZE UNK ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention