BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM XL INSULATED DILATORS

    MDR report key: 8901668 · Received August 15, 2019

    Report

    Report Number
    MW5089090
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 13, 2019
    Manufacturer
    TEDAN SURGICAL INNOVATION LLC
    Product Code
    PDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY ON (B)(6) 2019, FIRST STAGE OF 2 PART SURGICAL SPINE PROCEDURE. DILATOR TIP BROKE IN L3-4 DISC SPACE. SURGEON ATTEMPTED TO RETRIEVE TIP BUT WAS NOT ABLE TO. PT WAS ALREADY SCHEDULED FOR SECOND PROCEDURE (B)(6) 2019. SURGEON COMPLETED SECOND SURGERY ON (B)(6) 2019 AND WAS ABLE TO RETRIEVE BROKEN DILATOR TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693472 PHANTOM XL INSULATED DILATORS NEUROSUGICAL NERVE LOCATOR PDQ TEDAN SURGICAL INNOVATION LLC ML-0441S 2019020501

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR