BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1542430 · Received November 2, 2009

    Report

    Report Number
    1030489-2009-01035
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    October 3, 2009
    Report Date
    October 3, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE SUSPECT DEVICES IN USE ARE LOT # 0010715W, 0012736W, 0028025W, AND 0030757W. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS. THIS PART IS NOT APPROVED FOR USE IN THE US; HOWEVER, A LIKE DEVICE CATALOG #6950305, 510K # K042498 WAS CLEARED IN THE US. MANUFACTURE DATE FOR LOT 0010715W IS 02/12/2009; MANUFACTURE DATE FOR LOT 0012736W IS 03/09/2009; MANUFACTURE DATE FOR LOT 0028025W IS 05/14/2009; MANUFACTURE DATE FOR LOT 0030757W IS 06/09/2008. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PROCEDURE AT OCCIPUT TO C3 USING POSTERIOR FIXATION. IT WAS REPORTED THAT WHILE PLACING AN OC PLATE ON, THE SCREWDRIVER SLIPPED AND DAMAGED THE SET SCREW HEAD ON THE CAUDAL SITE. THE SURGEON TRIED TO REPLACE THE SET SCREW, HOWEVER, OTHER SET SCREWS ALSO FAILED TO BE IMPLANTED. THEREFORE, THE SET SCREW AT THE RIGHT CAUDAL SIDE WAS NOT IMPLANTED. ONLY TWO OF THE THREE SET SCREWS WERE IMPLANTED ON THE RIGHT SIDE. THE PROBLEM SUSPECTED TO BE THE INTERFACE BETWEEN THE ROD AND THE SET SCREW. IT ALSO COULD BE THE SET SCREWS WERE CROSS THREADED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR