BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3466089 · Received November 13, 2013

    Report

    Report Number
    1030489-2013-04486
    Event Type
    Malfunction
    Date Received
    November 13, 2013
    Date of Event
    September 30, 2013
    Report Date
    November 27, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS SUPPLIED FOR REVIEW SHOWED: TWO AP VIEWS OF CERVICAL FUSION USING VERTEX LATERAL MASS SCREWS. THE INITIAL VIEWS SHOW THE CONSTRUCT EXTENDING C4-C7. SUBSEQUENT FILMS SHOW C2- C7 CONSTRUCT WITH AN EXTENSION USING LATERAL CONNECTORS AND REMOVAL OF TWO C4 AND C5 SCREWS. THE LATERAL CONNECTORS USED TO SPAN THE TWO CONSTRUCTS HAVE COME LOOSE ON ONE SIDE ALLOWING THE RODS TO COME APART.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7750444, 510K # K090714 WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE PROTRUSION AND SURFACE. NO DAMAGE IDENTIFIED TO SET SCREW THREAD CREST OR FLANKS. PROTRUSION HEIGHT AND MORPHOLOGY OF DEFORMATION FOUND TO BE CONSISTENT OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) CONSISTENT WITH COMPARISON SAMPLES. AFTER VISUAL AND OPTICAL AND MICROSCOPIC EXAMINATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS; UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A C4-7 FUSION. SOMETIME POST-OP THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO EXTEND THE CONSTRUCT UP TO C2 AND THE SCREWS AT C6 AND 7 WERE REPLACED AND A DOMINO CONNECTOR WAS ADDED. SIX DAYS LATER IT WAS FOUND THAT THE DOMINO CONNECTOR HAD MIGRATED. A REVISION SURGERY WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586970 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0192926W

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention