BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7432423 · Received April 16, 2018

    Report

    Report Number
    1030489-2018-00565
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 30, 2018
    Report Date
    April 16, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 7752500, 510K#K062879 AND UPN (B)(4) IS AVAILABLE FOR THE MARKET. THE DEVICE WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE CERVICAL STENOSIS AND DEGENERATION UNDERWENT POSTERIOR CERVICAL AND UPPER THORACIC FUSION AT LEVELS OCCIPUT TO T4. INTRA-OP, THE TOP PORTION WHERE THE HEX PART OF THE MAS CONNECTOR SET SCREW SHEARED OFF THE BOTTOM PORTION OF THE SET SCREW. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO FRAGMENTS WERE REMAINING INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276619 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR