BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSOM ANTERIOR CERVICAL PLATE

    MDR report key: 6190072 · Received December 20, 2016

    Report

    Report Number
    3008853203-2016-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 31, 2016
    Manufacturer
    NEUROSTRUCTURES,INC.
    Product Code
    KWQ
    UDI-DI
    00841508101666
    PMA / PMN Number
    K142060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOGRAPHS CONFIRMING THE EVENT WERE RECEIVED BY (B)(4) (DISTRIBUTOR). PRODUCT HAS NOT BEEN RETURNED BECAUSE THE DEVICE REMAINS IMPLANTED. PLEASE NOTE THIS IS MY FIRST ELECTRONIC MDR AND THE DELAY OF THE SUBMISSION IS DUE TO THE SIGNUP PROCESS. DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    INITIAL ACDF SURGERY AT C4-C6 WAS PERFORMED ON (B)(6) 2016. ROUTINE FOLLOW UP AT 2 WEEKS NOTED NO CHANGE TO THE DEVICE. APPROXIMATELY 6 WEEKS POST OPERATIVELY, IT WAS NOTED THAT THE 18MM CAUDAL BONE SCREW HAD BACKED OUT 2-3MM FROM THE ANTERIOR CERVICAL PLATE. PATIENT IS ASYMPTOMATIC. SURGEON IS MONITORING THE PATIENT, AND NO REVISION SURGERY IS CURRENTLY PLANNED. PATIENT BONE QUALITY IS UNKNOWN. THE PATIENT REPORTEDLY DID NOT FALL PRIOR TO THE EVENT. IT IS UNKNOWN IF THE PATIENT COMPLIED W/POST-OPERATIVE CARE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840754 TRANSOM ANTERIOR CERVICAL PLATE APPLIANCE,FIXATION, SPINAL, INTERVERTEBRAL BODY KWQ NEUROSTRUCTURES,INC. 00841508101666

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR