BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3111377 · Received May 14, 2013

    Report

    Report Number
    1030489-2013-01687
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL REVIEW CONFIRMS SCREW BREAKAGE APPROXIMATELY 1-2 THREADS FROM THE BASE OF THE BONE SCREW HEAD. OPTICAL EXAMINATION OF ADJACENT SURFACES AROUND THE AREA OF CRACK PROPAGATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. FRACTURE SURFACE DAMAGE NOTED ON BROKEN OFF PORTION OF THE BONE SCREW FRACTURE SURFACES. THE LOWER BROKEN PORTION OF THE BONE SCREW IS CONSISTENT WITH EXPLANTATION. FRACTURE SURFACE EXAMINATION IDENTIFIED A MULTI-MODAL FRACTURE, WITH PROGRESSIVE STRIATIONS EMANATING AWAY FROM THE AREA OF ORIGIN OF INITIAL FRACTURE PROPAGATION AS NOTED, AS WELL AS INCREASED MATERIAL DISRUPTION AT APPROXIMATELY 50% THROUGH THE CROSS-SECTIONAL AREA, AND SHEAR LIPS ON BOTH SIDES OF THE FRACTURE, CONSISTENT WITH OVERLOAD. DIMENSIONAL EXAMINATION CONFIRMED CONFORMANCE TO PRINT SPECIFICATION OF THE BONE SCREW DIAMETER AT THE BASE OF THE HEAD. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE AT TH11-L4. THE PATIENT COMPLAINED OF PAIN AND AN X-RAY WAS TAKEN CONFIRMING A FRACTURED SCREW. IT WAS REPORTED THAT A REMOVAL SURGERY WAS COMPLETED DUE TO A SCREW FRACTURE FROM A PREVIOUS SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211999 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10L0079

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR