BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2920048 · Received January 17, 2013

    Report

    Report Number
    1030489-2013-00158
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE BREAK-OFF PORTION OF THE SET SCREW WAS RETURNED FOR ANALYSIS. VISUAL AND OPTICAL EXAMINATION IDENTIFIED WITNESS MARKS AND PLASTIC DEFORMATION ON THE INTERIOR OF THE IMPLANT, WITH CROSS SECTIONAL RIVER LINES. MATERIAL THICKNESS INSPECTED AND FOUND TO BE WITHIN PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L4-S1. IT WAS REPORTED THAT DURING FINAL TIGHTENING AT THE LEFT L5 PEDICLE, THE BREAK OFF PORTION OF THE SET SCREW SPLIT IN HALF. THE SURGEON WAS ABLE TO USE PLIERS TO REMOVE THE REMAINING PORTION OF THE BREAK OFF AREA. THE SURGEON COMMENTED THAT THE INCIDENT WAS CAUSED BY A HUMAN ERROR BECAUSE HE DID NOT USE A COUNTER TORQUE WHEN HE BROKE OFF THE SETSCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25559 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H11B8855

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW