BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2003995 · Received March 1, 2011

    Report

    Report Number
    1030489-2011-00217
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K071942
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RODS WERE RETURNED FOR EVALUATION. VISUALLY CONFIRMED BOTH RODS BROKEN AT BASE OF CONNECTORS. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE ANALYSIS REVEALS A QUASI-BRITTLE FRACTURE WITH INDICATIVE OF FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT, CONSISTENT WITH FAILURE DUE TO HIGH-CYCLE FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL SURGICAL PROCEDURE AT OCCIPUT- T2. SOMETIME POST-OP, IT WAS REPORTED THAT THE RODS BROKE AT THE INTERFACE TO THE HINGE. THE PATIENT REPORTED NECK PAIN. THE PATIENT UNDERWENT A REVISION SURGERY TO DECOMPRESS AND REPLACE THE RODS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS