BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3892410 · Received June 24, 2014

    Report

    Report Number
    1030489-2014-02865
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CT SCAN IS PROVIDED POSTOPERATIVELY OF AN L4/5 FUSION USING PEDICLE SCREWS AND PEEK RODS. AXIAL BONE AND SOFT TISSUE WINDOWS ARE PROVIDED. THE CT SCAN VERIFIES BREAKAGE OF BOTH L5 SCREWS IN MID PEDICLE. NO LOSS OF ALIGNMENT OF THE INTERVAL IS SEEN. NO INTER BODY DEVICE IS SEEN ON CT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL EXAMINATION OF THE MAS BONE SCREW CONFIRMED BONE SCREW COMPLETE FRACTURE AT APPROXIMATELY ~7 THREADS FROM THE BASE OF THE BONE SCREW HEAD. VISUAL AND OPTICAL INSPECTION OF THE BONE SCREW SURFACE IMMEDIATELY ADJACENT TO THE FRACTURE DID NOT IDENTIFY MATERIAL SURFACE DEFECT WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. SIGNIFICANT FRACTURE SURFACE SMEARING AND DAMAGE IS NOTED. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURE, WITH INITIAL FAIRLY FLAT REGION APPROXIMATELY 20% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, WITH EVIDENCE OF RATCHET MARKS, BEACH MARKS, PROGRESSIVE STRIATIONS, WHICH ARE ALL CONSISTENT WITH CYCLIC FATIGUE. THE REMAINING PORTION OF THE CROSS-SECTIONAL AREA ¿THIS IS FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, RIVERLINES AND SOME EVIDENCE OF SHEAR LIPS, WHICH ARE CONSISTENT WITH OVERLOAD, AND WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER BOTH ABOVE AND BELOW THE FRACTURE WITHIN PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE AT L4-5. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT A SCREW WAS BROKEN. A REVISION IS PLANNED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367611 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG H12E3081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other