BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1020997 · Received March 28, 2008

    Report

    Report Number
    1030489-2008-00164
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 28, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K003780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH AN ANTERIOR FRACTURE AT T1 UNDERWENT SURGERY FOR A TOTAL CORPECTOMY AT T1 WITH POSTERIOR FIXATION AT C5-T4 WITH 3.2MM AND 5.5MM RODS AND A FIBULAR STRUT FROM C7-T2 WITH ANTERIOR PLATE. IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY, TO REMOVE A BROKEN 3.2MM THREADED ROD, THAT WAS BROKEN AT THE 3.2 TO 5.5MM ROD CONNECTION. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM THREADED ROD KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention