BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1894892 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01451
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    September 1, 2010
    Manufacturer
    WARSAW ORTHOPEDIC. INC.
    Product Code
    KWQ
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MACROSCOPIC AND OPTICAL EXAMINATION OF THE SET SCREWS IDENTIFIED ATYPICAL ROD INTERFACE WITNESS MARKS, CONSISTENT WITH INAPPROPRIATE ROD PLACEMENT, AND RESULTING IN INSUFFICIENT RETENTION OF THE ROD AND THE FOREGOING EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCE TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION PROCEDURE AT L4-5 USING POSTERIOR FIXATION. AN UNK TIME POST-OP, IT WAS NOTED THAT THE RODS HAD MIGRATED OUT OF THE INFERIOR SCREWS, AND THE SETSCREWS WERE LOOSE. THE PATIENT UNDERWENT A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SETSCREW KWQ WARSAW ORTHOPEDIC. INC. NA 0042641W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention