BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1152829 · Received September 4, 2008

    Report

    Report Number
    1030489-2008-00486
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K003780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECT DEVICES IN USE ARE PART #G9655406, LOT W05L0074; PART # G6955408, LOT W05K2299; PART #G6955410, LOT W07E1587. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE AT OCCIPITAL-C7 USING POSTERIOR FIXATION. IT WAS NOTICED THAT A CORTICAL SCREW OF THE MID-LINE PLATE WAS LOOSENED POST-OP. THE REVISION SURGERY TO REPLACE THE LOOSENED SCREW WITH THE LARGER SIZED SCREW WAS PERFORMED APPROX TWO WEEKS POST-OP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention