BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: CERVIOS

    MDR report key: 11731531 · Received April 27, 2021

    Report

    Report Number
    8030965-2021-03298
    Event Type
    Injury
    Date Received
    April 27, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    ODP
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACERS: CERVIOS/UNKNOWN LOT. PART AND LOT NUMBERS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MACCORMICK A., SHARMA H., (2020) ANALYSIS OF THE VARIABLE AFFECTING THE INCIDENCE , LOCATION, AND SEVERITY OF CAGE SUBSIDENCE FOLLOWING ANTERIOR CERVICAL DISCECTOMY AND FUSION OPERATION, INTERNATIONAL JOURNAL OF SPINE SURGERY , VOLUME 14 (6), PAGES 896-900 (UNITED KINGDOM). THIS RETROSPECTIVE STUDY AIMS TO ANALYZE THE VARIABLES AFFECTING THE INCIDENCE, LOCATION, AND SEVERITY OF CAGE SUBSIDENCE FOLLOWING ACDF OPERATION. BETWEEN 2013 AND 2017, 77 CONSECUTIVE PATIENTS, 48 MALES AND 29 FEMALES (95 LEVELS) WITH MEAN AGE OF 58 YEARS (RANGE 27¿83 YEARS) WITH 16 (21%) BEING OVER THE AGE OF 65 YEARS AND WHO UNDERWENT ACDF WERE INCLUDED IN THE STUDY. THE CAGES USED WERE EITHER RABEA OR CERVIOS-SYNTHES,AND THE SIZES RANGED FROM 5 TO 7 MM. THE MEAN POSTOPERATIVE FOLLOW-UP WAS 10 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE OVERALL INCIDENCE OF CAGE SUBSIDENCE WAS (32/ 95 LEVELS). OF THESE 32 LEVELS, THE MAJORITY OF THE SUBSIDENCE WAS BETWEEN 2 AND 4 MM (20/32) WITH ANOTHER 9 LEVELS SHOWING SUBSIDENCE OF LESS THAN 2 MM AND ONLY 3 LEVELS WITH SUBSIDENCE OF OVER 5 MM. A SIGNIFICANTLY GREATER INCIDENCE OF SUBSIDENCE WAS RECORDED WITH ANTERIORLY POSITIONED CAGES COMPARED WITH CENTRAL OR POSTERIORLY POSITIONED CAGES. THIS REPORT IS FOR AN UNKNOWN SYNTHES CERVIOS CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630140 UNK - CAGE/SPACERS: CERVIOS INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention