BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 2112069 · Received June 2, 2011

    Report

    Report Number
    1030489-2011-00659
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 25, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT SWINNEA DC
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICES FOUND THAT THE CROWNS ARE SHOWING IMPACTIONS DUE TO TIGHTENING WITH A SPINAL ROD. FOR ALL MULTI-AXIAL SCREWS, THE DEFORMATION IS SYMMETRICAL WHICH IS CONSISTENT WITH PROPER TIGHTENING OF THE CONNECTION. 3 OF THE 4 MULTI-AXIAL SCREWS PRESENT WHITE MASS (POSSIBLY BONE CEMENT) EITHER AT THE JUNCTION OF THE BONE SCREW AND THE SCREW HEAD, ON THE INNER THREAD OR THE LATERAL HOLE ON THE SCREW HEAD. THE INNER THREADS OF THE MULTI-AXIAL SCREWS PRESENT VERTICAL SCRATCHES COMING FROM THE EXPLANTATION MANEUVERS. THE EDGE OF ONE CROWN HAS BEEN DEFORMED DURING THE EXPLANTATION MANEUVERS. BASED ON THE OBSERVATIONS AND THE PROVIDED INFORMATION, THE EVENT SEEMS NOT RELATED TO THE DEVICES.

    Additional Manufacturer Narrative · 1

    THE PART AND LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWE VER, THE SUSPECT DEVICES IN USE ARE PART# 86745550 LOT # W06H0766, PART# 86746545 LOT# W06H0767, AND PART# 86745545 LOT# W06A4446. (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. MANUFACTURE DATE FOR PART # 86745550 LOT W06H0766 IS 8/3/2006; MANUFACTURE DATE FOR PART # 86746545 LOT W06H0767 IS 8/9/2006; MANUFACTURE DATE FOR PART # 86745545 LOT W06A4446 IS 2/1/2006. REVIEW OF MULTIPLE X-RAYS SHOW SEXTANT SCREWS PLACED L2-L4 WITH COMPRESSION FRACTURE AT L3. NO INTERPEDICULAR WIDENING TO SUGGEST INSTABILITY OR BURST. THEREFORE SURGICAL INDICATIONS ARE NOT CLEAR. REPORTED L2 FRACTURE IS NOT SUPPORTED BY X-RAY FILMS. RODS AND SCREWS EVENTUALLY REMOVED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE USING POSTERIOR FIXATION. AN UNKNOWN TIME POST OP, A FRACTURE WAS OBSERVED AT L2, AND THE BONE SCREWS WERE LOOSE. THE PATIENT UNDERWENT A REVISION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SWINNEA DC 522550

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention