BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7917775 · Received September 28, 2018

    Report

    Report Number
    1030489-2018-01309
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    August 31, 2018
    Report Date
    January 16, 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 US, HOWEVER, A LIKE DEVICE WITH PART 7753500, 510K# K082728 AND UPN (B)(4) IS APPROVED IN THE US. H6: PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE RETURNED PART DOES NOT APPEAR TO HAVE FAILED. AT THIS TIME THE ROOT CAUSE OF THE FAILURE CAN NOT BE DETERMINED AS THE ACTUAL FAILED PRODUCT DOES NOT APPEAR TO HAVE BEEN RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE USED: POSTERIOR CERVICAL FUSION IT WAS REPORTED THAT INTRA-OP, WHEN PERFORMING FUSION AT C2/7, THE PHYSICIAN ATTEMPTED TO PLACE CROSSLINK ON C4, SETSCREW BROKE. IT WAS BROKEN OFF FROM THE ROOT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO CONSEQUENCES AND SYMPTOMS REPORTED TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759830 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0657177W

    Patients

    Seq Age Sex Outcome Treatment
    1