BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1488413 · Received August 11, 2009

    Report

    Report Number
    1030489-2009-00754
    Event Type
    Malfunction
    Date Received
    August 11, 2009
    Date of Event
    July 21, 2009
    Report Date
    July 13, 2009
    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). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# 0010715W, 0012732W, 0012733W, AND 0012734W. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6950305, 510K # K042498 WAS CLEARED IN THE UNTIED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE A BROKEN ROD AT O/C1. IT WAS FOUND AT THE REVISION SURGERY THAT BOTH SET SCREWS AT C2 WERE LOOSENING. THE SCREWS WERE REPLACED AT THIS REVISION PROCEDURE AS WELL

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention