BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSOM ANTERIOR CERVICAL PLATE

    MDR report key: 6062584 · Received October 27, 2016

    Report

    Report Number
    3012120772-2016-00013
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 30, 2016
    Report Date
    September 30, 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. DHR REVIEW AND PRODUCT INVESTIGATION CANNOT BE COMPLETED AS THE PRODUCT HAS NOT BEEN RETURNED BECAUSE THE DEVICE REMAINS IMPLANTED. COMPLAINT INFORMATION HAS BEEN FORWARDED TO (B)(4) THE MANUFACTURER. 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 18 MM 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
    712982 TRANSOM ANTERIOR CERVICAL PLATE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NEUROSTRUCTURES. INC 00841508101666

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR