BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS TI CFX FEN POLY 8X80

    MDR report key: 2880035 · Received December 19, 2012

    Report

    Report Number
    1526439-2012-00309
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MNI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES SPINE HAS REQUESTED RETURN OF THE SCREW. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED SCREW FOUND THE SCREW HEAD HAD BROKEN OFF AT THE BASE IN THE AREA WHERE IT MEETS THE SCREW SHAFT. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, THE MIS TI CFX FENESTRATED POLYAXIAL SCREW IS INTENDED FOR USE IN PATIENTS WITH DIMINISHED BONE QUALITY. THE PATIENTS GOOD BONE QUALITY LIKELY PRESENTED A HIGHER THAN ANTICIPATED TORQUE DURING INSERTION OF THE POLYAXIAL SCREW, RESULTING IN SCREW HEAD DISLODGEMENT. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INTRA-OPERATIVELY , TWO SCREWS BROKE DURING INSERTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY AS OTHER SCREWS WERE AVAILABLE TO COMPLETE THE PROCEDURE. SEE MFG MEDWATCH REPORT# 1526439-2012-00310 FOR THE SECOND SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS TI CFX FEN POLY 8X80 ORTHOSIS, SPINAL PEDICLE FIXATION MNI DEPUY RAYNHAM TBAV1

    Patients

    Seq Age Sex Outcome Treatment
    1 279712400, EXPEDIUM POLY SCREWDRIVER