BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREMER 3D CROWN FULL ASSEMBLY

    MDR report key: 3030249 · Received April 2, 2013

    Report

    Report Number
    1526439-2013-14720
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    JEC
    PMA / PMN Number
    PK915800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER OR SAMPLE WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF COMPLAINT DATA FOUND NO EMERGING TRENDS. NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED FOR THE PAST TWELVE MONTHS. THE PATIENT IS REPORTED TO HAVE POOR BONE QUALITY WHICH MAY HAVE CONTRIBUTED TO THE EVENT. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING APPLICATION OF THE 3D HALO CROWN ASSEMBLY, ONE SKULL PIN PENETRATED THE PATIENT'S SKULL. THE PIN WAS REMOVED AND REPLACED AND THE HALO CROWN WAS APPLIED. THE PATIENT IS REPORTED TO HAVE NOT HAVE ANY HEALTH PROBLEMS AND NO ADDITIONAL TREATMENT WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT'S BONE QUALITY IS NOT VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134985 BREMER 3D CROWN FULL ASSEMBLY COMPONENT, TRACTION, INVASIVE JEC DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention