BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 9676722 · Received February 6, 2020

    Report

    Report Number
    1526439-2020-00502
    Event Type
    Injury
    Date Received
    February 6, 2020
    Report Date
    January 16, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN PEEK CAGE /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YAN, S.Z., DI., J., AND SHEN, Y. (2017), ADJACENT SEGMENT DEGENERATION FOLLOWING ANTERIOR CERVICAL DISCECTOMY AND FUSION VERSUS THE BRYAN CERVICAL DISC ARTHROPLASTY, MEDICAL SCIENCE MONITOR, VOL. 23, PAGES 2692-2700 (CHINA). THE AIM OF THIS STUDY WAS TO INVESTIGATE THE RISK FACTORS FOR ADJACENT SEGMENT DEGENERATION FOLLOWING ACDF COMPARED WITH THE USE OF THE BRYAN ARTIFICIAL DISC FOR CERVICAL DISC ARTHROPLASTY (CDA). FROM DECEMBER 2002 TO DECEMBER 2004, A TOTAL OF 39 PATIENTS (24 MALES AND 15 FEMALES) WHO UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION USING A PEEK-CAGE (DEPUY CO.). ALL PATIENTS WERE REQUIRED TO COMPLETE CLINICAL AND RADIOLOGICAL EVALUATION BEFORE SURGERY, AND AT THREE DAYS, THREE MONTHS, ONE YEAR, AND THREE YEARS POSTOPERATIVELY, WITH THE LAST FOLLOW-UP AT MORE THAN 96 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: 19 PATIENTS HAD ADJACENT SEGMENT DEGENERATION. FOLLOW-UP X-RAYS SHOWED SOLID FUSION WITH AN ABSENCE OF MOVEMENT IN ALL BUT ONE CASE (AT 13-MONTH FOLLOW-UP), WHO SHOWED SLIGHT MOVEMENT IN THE OPERATED LEVEL DESPITE CLINICAL IMPROVEMENT. THIS REPORT IS FOR A PEEK-CAGE (DEPUY CO.). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141619 UNKNOWN CAGE/SPACER ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention