BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER HALO CROWN SET LARGE

    MDR report key: 2421948 · Received January 19, 2012

    Report

    Report Number
    1526439-2012-00016
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 5, 2011
    Report Date
    January 19, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JEC
    PMA / PMN Number
    ?K915800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND THAT THE PRODUCT WAS MADE TO SPECIFICATION. THE DIFFICULTY IN USE CAN BE ATTRIBUTED TO VARIATION WITHIN THE MANUFACTURING TOLERANCE. IF THIS OCCURS IT CAN MAKE IT MORE DIFFICULT TO ATTACH THE VEST TO THE CROWN, RESULTING IN AN EXTENSION IN THE APPLICATION TIME. THE DEVICE WAS NOT RETURNED AS IT IS CURRENTLY APPLIED TO THE PATIENT. IT WAS ABLE TO BE FULLY TIGHTEN AND AS SUCH WILL PERFORM ITS INTENDED FUNCTION.

    Description of Event or Problem · 1

    DURING STABILIZATION OF CERVICAL FRACTURE THE PLACEMENT OF THE CROWN ON THE SKULL WAS IN ACCORDANCE WITH THE PROCEDURE DESCRIPTION. WHEN THE HCP WANTED TO CONNECT THE JOINTS ON THE TRANSVERSE BARS (FROM THE SUPERSTRUCTURE AIRFLO VEST) TO THE TOOTHED JOINTS ON THE CROWN HE NOTICED THAT THE TEETH DO NOT FIT WELL WITH EACH OTHER. THE USER TIGHTENED THE CONNECTING BOLTS DOWN AND COMPLETED THE APPLICATION PROCESS. THERE WAS NO ADVERSE PATIENT OUTCOME. THE SITUATION DID CAUSE A EXTENSION OF APPLICATION TIME AND AS A RESULT OF THE DELAY AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER HALO CROWN SET LARGE COMPONENT, TRACTION, INVASIVE JEC DEPUY RAYNHAM 061034

    Patients

    Seq Age Sex Outcome Treatment
    1