BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSOM ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6407105 · Received March 15, 2017

    Report

    Report Number
    3012120772-2017-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 15, 2017
    Manufacturer
    NEUROSTRUCTURES. INC
    Product Code
    KWQ
    UDI-DI
    00841508101819
    PMA / PMN Number
    K142060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOGRAPHS CONFIRMING THE EVENT WERE RECEIVED. DHR REVIEW AND PRODUCT INVESTIGATION CANNOT BE COMPLETED AS THE PRODUCT HAS NOT BEEN RETURNED BECAUSE THE DEVICE WAS DISCARDED AFTER REVISION (B)(6) 2017. NO SCREWS WERE REPLACED AT THAT C7 AT THE SURGEON DISCRETION. PLATE REMAINS IN THE PATIENT. COMPLAINT INFORMATION HAS BEEN FORWARDED TO NEUROSTRUCTURES INC. THE MANUFACTURER, WHO ALSO SUBMITTED MEDWATCH 3500A REPORT NUMBER 3008853203-2017-00002.

    Description of Event or Problem · 1

    SURGERY WAS C4-C7 ACDF AND A PARTIAL CORPECTOMY ON (B)(6) 2016. CERVICAL PLATE MIGRATION. SCREWS BACKED OUT OF THE CERVICAL PLATE AT C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187908 TRANSOM ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NEUROSTRUCTURES. INC 00841508101819

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention