BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3223798 · Received July 12, 2013

    Report

    Report Number
    1030489-2013-03012
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EXAMINATION OF THE MAS BONE SCREW CONFIRMED BONE SCREW COMPLETE FRACTURE AT APPROXIMATELY ~2-3 THREADS FROM THE BASE OF THE BONE SCREW HEAD. VISUAL AND OPTICAL INSPECTION OF THE BONE SCREW SURFACE DID NOT IDENTIFY WITNESS MARKS OR OTHER DAMAGE NEAR THE FRACTURE SURFACE INITIATION AREA WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALS DAMAGE AND FRACTURE SURFACE SMEARING. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED PROGRESSIVE STRIATIONS, WHICH ARE INDICATIVE OF FATIGUE. DIMENSIONAL INSPECTION OF MAJOR AND MINOR DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT COMPONENTS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L5-S1. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 8 YEARS POST-OP DUE TO THE SCREW BEING BROKEN IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321367 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W05F5620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention