BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE SIZE 3 SLIDING CORE 7.5MM

    MDR report key: 1913985 · Received November 30, 2010

    Report

    Report Number
    1526439-2010-00173
    Event Type
    Injury
    Date Received
    November 30, 2010
    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

    BASED ON THIS INFORMATION IT APPEARS THAT THE PATIENT HAD INSTABILITY OF THE REGION, AND MIGRATION WAS RELATED TO ANATOMICAL RELATED ISSUES AND / OR DUE TO TRAUMA (FALLING / LIFTING). NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. THE SURGEONS IN THE ARTICLE CONCLUDED THAT THE ALTERED BIO-MECHANICAL FORCES THAT WERE GENERATED OVER TIME MAY HAVE LED TO DEVICE FAILURE.

    Description of Event or Problem · 1

    AN ARTICLE (B)(4) PUBLISHED IN SPINE DETAILED AN ADVERSE OUTCOME FOR A CHARITE DISC PATIENT. IN SUMMARY, (B)(6) FEMALE EXPERIENCED POST OP MIGRATION OF THE SLIDING CORE. A REVISION WAS PERFORMED REMOVING THE 7.5MM CORE AND REPLACING IT WITH A LARGER 9.5 SIZE. PATIENT CONTINUED TO HAVE PAIN AND POSTERIOR FIXATION WAS ADDED L5/S1. EIGHT WEEKS LATER PATIENT EXPERIENCED SEARING PAIN WHEN LIFTING A POT OF FLOWERS. CT SCANS SHOWED POSTERIOR HARDWARE LOOSENING AND POSTERIOR CORE MIGRATION. ANOTHER REVISION WAS PERFORMED. THE CORE WAS REMOVED (ENDPLATES REMAIN IN VIVO) AND CONSTRUCT EXTENDED FROM L4-PELVIS. SEE ALSO: 1526439-2010-00174.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE SIZE 3 SLIDING CORE 7.5MM ARTIFICIAL DISC MJO DEPUY SPINE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention