BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE BULLET PARALLEL 9X10X27

    MDR report key: 2881975 · Received December 20, 2012

    Report

    Report Number
    1526439-2012-84020
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    February 13, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED CONCORDE BULLET CAGE REVEALED SLIGHT MARKINGS NEAR THE THREADED HOLE OF THE CAGE. THESE MARKINGS SUGGEST THAT THE INSERTER MADE SOME LEVEL OF CONTACT WITH THE CAGE. NO OTHER VISUAL ANOMALIES WERE NOTED ON THE CAGE. TESTING OF THE RETURNED CONCOMITANT DEVICE TORQUE WRENCH HANDLE USED TO TIGHTEN THE SET SCREWS FOUND THE TORQUE WAS OUT OF SPECIFICATION BY -0.8 IN-LBS. HOWEVER, IT WAS DETERMINED THAT THIS CONDITION WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. EXAMINATION OF PROVIDED X-RAYS FOUND THE SPINAL ROD SELECTED BY THE SURGEON MAY NOT HAVE HAD THE NEEDED LENGTH, THEREFORE RESULTING IN THE TIGHTENED SET SCREW NOT FULLY CAPTURING THE ROD. THIS CONDITION MAY HAVE CAUSED OR CONTRIBUTED TO POSTERIOR MIGRATION OF THE CAGE. REVIEWS OF THE DEVICE HISTORY RECORD FOR THE CAGE AND CONCOMITANT DEVICES FOUND NO DISCREPANCIES. NO DEFINITIVE CONCLUSIONS CAN BE MADE. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RIGHT SIDE: STABILIZATION L4 TO S1. ON THE RIGHT SIDE, THE ROD SLIPPED FROM THE HEAD OF THE POLYAXIAL SCREW AT L4. LEFT SIDE: L4 - L5 SET SCREWS WERE LOOSE. SET SCREW AT SI REMAINED FIXED WITH NO ROD SLIPPAGE. AS REPORTED, THE CONCORDE CAGE SLIPPED INTO THE SPINAL CANAL CAUSING PAIN AND PROGRESSIVE LEG PARESIS. REVISION SURGERY WAS PERFORMED AND THE CAGE AND TWO SET SCREWS WERE REMOVED. CONCOMITANT DEVICES: EXPEDIUM SI SET SCREW, 179702000; TORQUE WRENCH HANDLE, 277040510; 279712600, EXPEDIUM X25 HEX DRIVER

    Description of Event or Problem · 1

    ADDITIONAL CONCOMITANT DEVICES: TWO EXPEDIUM RODS, CATALOG NUMBER UNKNOWN. THE RODS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCORDE BULLET PARALLEL 9X10X27 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ANBDCF

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention