BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2202757 · Received August 11, 2011

    Report

    Report Number
    1030489-2011-01031
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6)-2008. (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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CROWN IS SHOWING IMPACTIONS DUE TO TIGHTENING WITH A SPINAL ROD. THE DEFORMATIONS ARE ASYMMETRICAL, CONSISTENT WITH THE TRANSMISSION OF FLEXURAL LOADS THROUGH THE CONNECTION. THE BONE SCREW IS BROKEN AT THE SECOND THREAD FROM THE NECK. THE FRACTURE APPEARANCE IS OF METAL FATIGUE TYPE, WITH VISIBLE LINES OF REST PROPAGATING ACROSS THE SECTION. THE GEOMETRY OF THE FRACTURE ALLOWS IDENTIFICATION OF THE STARTING POINT AND THE DIRECTION OF PROPAGATION ACROSS THE SECTION. THE BROKEN BONE THREAD IS DAMAGE DUE TO EXPLANTATION MANEUVERS THE BONE SCREWS RETURNED WAS FOUND BROKEN AT THE LEVEL OF THE BONE THREAD. NO DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE DAMAGES OBSERVED ARE CONSISTENT WITH A FATIGUE DAMAGING OF THE METAL DUE TO REPEATED FLEXURAL LOADING OF THE BONE SCREW. THE MAS WITH THE WORN PORTION OF THE BROKEN SECTION BROKE FIRST THEN FOLLOWED BY THE SECOND MAS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L5-S1 FUSION USING POSTERIOR FIXATION. THREE YEARS POST-OP, THE BONE SCREW IN S1 WAS FOUND TO BE BROKEN. THE L5-S1 LEVEL HAD NOT FUSED. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H09F7920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention