BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2112055 · Received June 2, 2011

    Report

    Report Number
    1030489-2011-00658
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K000453
    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 EACH ROD PRESENTS 2 MARKS COMING FROM THE TIGHTENING OF THE SETSCREWS. THE ANTERIOR SIDE OF THE EACH ROD PRESENTS 1 CONTACT WITH THE CROWN OF THE MAS ON ONE END AND 1 COMBINED CONTACT WITH THE CROWN OF THE MAS AND THE SERRATED PORTION OF THE MAS BONE SCREW ON THE OTHER END. THE COMBINED CONTACTS ARE DEEPER THAT THE CONTACTS WITH THE MAS CROWN ONLY. THE RODS HAVE BEEN TIGHTENED CORRECTLY ACCORDING TO THE MARKS ON THE RODS, THE SYMMETRICAL DEFORMATION OF THE MAS CROWN AND THE SMOOTH EDGES OF THE BOTTOM RING. BASED ON THE OBSERVATIONS AND THE PROVIDED INFORMATION, THE EVENT SEEMS NOT RELATED TO THE DEVICES.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # 522550, AND LOT# W04C3126. (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 LOT# 522550 IS 5/5/2003; MANUFACTURE DATE FOR LOT# W04C3126 IS 3/22/2004. 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. (B)(4).

    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 A ROD WAS 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 SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention