BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1939228 · Received December 28, 2010

    Report

    Report Number
    1030489-2010-01648
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    October 12, 2010
    Report Date
    December 2, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT #0063706W, EXPIRATION DATE 11/17/2017; LOT #0003707W, EXPIRATION DATE 11/13/2017; LOT #0066464W, EXPIRATION DATE 11/19/2017. AND LOT #0074578W, EXPIRATION DATE 01/14/2018. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6950305, 510K # K042498 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT W08E0313 IS 05/16/2008; THE MANUFACTURE DATE FOR LOT W08E1547 IS 6/4/2008; THE MANUFACTURE DATE FOR LOT 0063706W IS 11/23/2009; THE MANUFACTURE DATE FOR LOT 0063707W IS 12/01/2009; THE MANUFACTURE DATE FOR LOT 0066464W IS 11/20/2009; THE MANUFACTURE DATE FOR LOT 0074578W IS 01/22/2010. THE PRE-OP AND POST OP X-RAYS ARE SENT FOR EVALUATION. THE EVALUATION IS IN PROCESS. THE FOLLOW UP REPORT WILL BE SENT AFTER THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON- CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LATERAL FILMS ARE PROVIDED OF AN OCCIPUT TO C3 FUSION. LATERAL VIEW SCREWS AT C3 HAVE BECOME MAL-ALIGNED SUGGESTING ONE HAS TORN OUT AND MIGRATED. ALSO TWO SETS SCREWS ARE SEEN BACKED OUT ON (B)(6) 2010 FILM AT C3.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL POSTERIOR FIXATION PROCEDURE USING RODS AND SCREWS. APPROXIMATELY FOUR MONTHS POST OP, X-RAYS REVIEWED ONE OF THE SET SCREWS BACKED OUT. NO REVISION SURGERY IS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1