BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER 1/4" SQUARE QC 4.0

    MDR report key: 8011016 · Received October 26, 2018

    Report

    Report Number
    3009051471-2018-00009
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    April 27, 2018
    Report Date
    October 24, 2018
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    LXH
    UDI-DI
    00841732117853
    Removal / Correction Number
    300905147108022018-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST CUSTOMER COMPLAINT RECEIVED ON THE HEX DRIVER. COMPLAINT WAS DEEMED NOT REPORTABLE SINCE THERE WAS NO ADVERSE EVENT. FOLLOWUP ON SIMILAR DRIVERS RESULTED IN SIMILAR MALFUNCTION OF THE DEVICE. PRODUCT RECALL HAS INITIATED WITH A RECALL SUBMISSION # (B)(4). THIS REPORT IS IN ASSOCIATION WITH THE PRODUCT RELATED TO THE RECALL THAT HAD A SIMILAR MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STABILIZATION RING CAME OFF WHILE A SCREW WAS BEING INSERTED DURING A PROCEDURE. COMPLAINT WAS ASSESSED AND MDR WAS NOT FILED AS NO ADVERSE EVENT WAS REPORTED. REEVALUATION OF SIMILAR COMPLAINTS ON THE SIMILAR PRODUCTS SHOWED A TREND IN THE FAILURE MODES AND THESE COMPLAINTS ARE BEING REPORTED AS MDRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851032 HEX DRIVER 1/4" SQUARE QC 4.0 HEX DRIVER 1/4" SQUARE QC 4.0 LXH CTL MEDICAL CORPORATION 015.7050 7EQAB-D 00841732117853

    Patients

    Seq Age Sex Outcome Treatment
    1