BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2062320 · Received April 19, 2011

    Report

    Report Number
    1030489-2011-00437
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SCREW WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED MAS BROKEN. SEVERE DAMAGED NOTED ON BOTH FRACTURE SURFACES AND THREADS OF BONE SCREW. MICROSCOPIC EXAMINATION OF UNDAMAGED PORTIONS OF FRACTURE SURFACE REVEAL A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ONE LEVEL MINIMAL ACCESS DECOMPRESSION WITH RODS AND SCREWS AT L5-S1. APPROXIMATELY TWO YEARS POST-OP THE SCREW BROKE. THE PATIENT UNDERWENT A REVISION SURGERY TO HAVE THE BROKEN SCREW REMOVED AND REPLACED; ALSO AN INTERBODY DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA 0030486W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD