BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY SPINE 3D CROWN SYSTEM

    MDR report key: 1218316 · Received October 31, 2008

    Report

    Report Number
    1526439-2008-00184
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    IQF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION. IT IS UNLIKELY THAT WE WILL BE ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. AN EVENT OF THIS NATURE CAN OCCUR IF THE PIN IS CROSS THREAD INTO THE CROWN. IF THE DEVICE IS RETURNED AND AN EVALUATION CONCLUDES SOMETHING OTHER THAN WHAT IS STATED ABOVE A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT WHILE PLACING A CERVICAL CROWN ON A PATIENT ONE OF THE SKULL PINS BECAME STUCK, AND COULD NOT BE ADVANCED OR REMOVED. THE NEXT DAY THE CROWN WAS REMOVED AND REPLACED WITH ANOTHER. AS THE PROBLEM COULD NOT BE QUICKLY RESOLVED AN MDR BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE 3D CROWN SYSTEM EXTERNAL CERVICAL BRACE IQF DEPUY SPINE, INC. NA 060511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK