BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1854149 · Received September 3, 2010

    Report

    Report Number
    1030489-2010-01122
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NON-FUSION. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #6900280, 510K # K052402 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO FUSE O-C4 USING POSTERIOR FIXATION PLATE/ROD. THE CT PERFORMED THREE AND A HALF YEARS POST OP CONFIRMED THAT THE OC PLATE ROD BROKE AT C1. REPORTEDLY, THE PT COMPLAINED OF FEELING DISCOMFORT AFTER HE ROTATED HIS NECK. REPORTEDLY, FUSION OCCURRED IN C1-2, BUT FAILED AT O-C1. REVISION SURGERY MIGHT BE NEEDED TO FIX OCCIPIT USING A MIDLINE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM OCCIPITAL PLATE/ROD KWP WARSAW ORTHOPEDIC INC. NA W06A1938

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR EXPLANT DATE:| BONE SCREWS| IMPLANT DATE: