BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: SYNCAGE

    MDR report key: 9676891 · Received February 6, 2020

    Report

    Report Number
    8030965-2020-00901
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    June 1, 2017
    Report Date
    January 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN SYNCAGE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. (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 THE SYNCAGE-C (SYNTHES 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 AS FOLLOWS: 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 SYNCAGE-C (SYNTHES CO.). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140764 UNK - CAGE/SPACERS: SYNCAGE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention