BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON

    MDR report key: 2143450 · Received June 29, 2011

    Report

    Report Number
    1030489-2011-00828
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MDT SWINNEA DC
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMS THE BONE SCREW DISASSEMBLED FROM THE HEAD. THE RING AND CROWN WERE STILL ASSEMBLED IN THE HEAD. A PORTION OF THE RING HAS BEEN SHEARED OFF, WITH THE REMAINING PORTION OF RING STILL SEATED IN THE GROOVE OF THE HEAD. DIMENSIONAL INSPECTION OF BONE SCREW HEAD DIAMETER FOUND TO BE WITHIN PRINT SPECIFICATION. THE RETAINING RING IS FULLY SEATED, BUT HAS BEEN PARTIALLY SHEARED OFF, AND A PORTION OF THE RING IS BENT OUT OF THE RING GROOVE. THE PLASTICALLY DEFORMED / SHORN PORTION OF RETAINING RING OCCURRED WITHIN THE RETAINING RING SPACING GAP, WHICH WOULD REDUCE FORCE REQUIRED FOR RING FAILURE. FRACTURE SURFACE EXAMINATION SUGGESTS RETAINING RING SHEARING AS THE MECHANISM OF MATERIAL FAILURE. HEAVY WITNESS MARKS NOTED ON BOTH THE CROWN AND MATING PORTION OF THE BONE SCREW HEAD. FAILURE OCCURRED IN-SITU DURING BENDING, CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RECEIVED IN THE MANUFACTURER FOR EVALUATION. THE COMPLAINT PRODUCT PICTURE IS SENT TO THE MANUFACTURER. THE EVALUATION IS IN PROCESS. THE FOLLOW UP REPORT WILL BE SENT AFTER THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. DEVICE HISTORY RECORDS 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 FPINAL FIXATION PROCEDURE AT T/L JUNCTION. THE SCREW WAS IMPLANTED THEN IN-SITU BENDER WAS USED FOR ROD BENDING; THE SCREW HEAD BROKE AWAY FROM THE SCREW POST DURING THE BENDING PROCESS. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SWINNEA DC W08J2671

    Patients

    Seq Age Sex Outcome Treatment
    1