BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7982369 · Received October 18, 2018

    Report

    Report Number
    1030489-2018-01380
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 21, 2018
    Report Date
    March 15, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7752524, 510K #K123656, UDI#(B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL REVIEW OF THE CROSSLINK DID NOT IDENTIFY CRACK, FRACTURE, BREAKAGE OR DEFORMATION. THE CROSSLINK WAS RETURNED WITH THE HEX TIGHTENED. ONCE THE CROSSLINK NUT WAS LOOSENED A FUNCTIONAL CHECK CONFIRMED THE IMPLANT WAS ABLE TO SLIDE ACROSS THE ARMS OF THE CROSSLINK AND TIGHTEN WITH NO ISSUE. NO FAULT FOUND AS THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION. 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 POSTERIOR CERVICAL DISCECTOMY AND FUSION AT C1-4. DURING SURGERY, WHEN PERFORMING FINAL TIGHTENING OF MAS CROSSLINK LOCKING SCREW, THE HEX PART OF THE REPORTED PRODUCT MAS CROSSLINK SET SCREW WAS BROKEN. INSTEAD OF MAS CROSSLINK, TWO ROD CROSSLINK WERE INSTALLED AND COMPLETED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818056 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0523670W

    Patients

    Seq Age Sex Outcome Treatment
    1