BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2001818 · Received February 25, 2011

    Report

    Report Number
    1030489-2011-00210
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLATE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS IMPLANT ASSEMBLY SEPARATED. OPTICAL AND MICROSCOPIC EXAMINATION OF THE IMPLANT REVEALS RATCHET SPRING POCKET BROKEN. BONE SCREW WITNESS MARKS NOTED AT THE BASE OF THE ON SEPARATED COMPONENT SCREW HOLES. OPTICAL EXAMINATION REVEALS IMPLANT END COMP. RATCHETING CATCH FEATURES AND RATCHET SPRING POCKET PLASTICALLY DEFORMED, SUGGESTING TENSILE OVERLOAD. OBSERVATIONS ARE SIMILAR TO TENSILE OVERLOAD SAMPLES FOUND. ADDITIONALLY, PLATE SEPARATION OCCURRED INTRAOPERATIVELY DURING SCREW PLACEMENT; TESTING DETERMINED THAT HYPER ANGULATED OR OFF-CENTER SCREW INSERTION COULD RESULT IN LOADS CAPABLE OF DISASSEMBLING THE PLATES. THIS OBSERVATION, IN CONJUNCTION WITH THE AFOREMENTIONED PLASTIC DEFORMATION OF THE MATING RATCHETING COMPONENTS IS CONSISTENT WITH HYPER ANGULATED AND/OR OFF-CENTER SCREW INSERTION RESULTING IN THE AFOREMENTIONED PLATE DISASSEMBLY. 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 CERVICAL SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT DURING IMPLANTATION OF THE BONE SCREWS THE PLATE CAME APART. THE PLATE WAS REMOVED FROM THE PATIENT AND A NEW PLATE PLACED IN ITS PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA 0064105W

    Patients

    Seq Age Sex Outcome Treatment
    1