BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 10843605 · Received November 16, 2020

    Report

    Report Number
    1526439-2020-02197
    Event Type
    Injury
    Date Received
    November 16, 2020
    Report Date
    October 19, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/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. 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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TANIDA, S. ET AL. (2016), VERTEBRAL ENDPLATE CYST AS A PREDICTOR OF NONUNION AFTER LUMBAR INTERBODY FUSION, SPINE, VOOL. 41, NUMBER 20, PAGES E1216¿E1222 ((B)(6)). THE AIMS OF THIS STUDY WERE (I) TO INVESTIGATE WHETHER THE FORMATION OF BONE CYSTS AFTER TLIF USING PEEK CAGES IS A USEFUL SIGN FOR PREDICTING NONUNION, AS FOR TITANIUM (TI) CAGES; AND (II) FROM THE VIEWPOINT OF THE FORMATION OF VERTEBRAL ENDPLATE CYSTS, TO COMPARE THE BONE UNION RATE BETWEEN TI AND PEEK CAGES AFTER TLIF. FROM MARCH 2005 TO MARCH 2011, 93 LEVELS IN 77 PATIENTS (36 MALES ABD 41 FEMALES) WERE TREATED WITH TI CAGES. ALL TI CAGES WERE CRESCENT SHAPED AND INCLUDED EIGHT KIDNEY BEAN MESH CAGES (MEDTRONIC SOFAMOR DANEK, MINNEAPOLIS,MN), ONE DEVEX CAGE (DEPUY SYNTHES SPINE, RAYNHAM, MA), AND 84 BOOMERANG II CAGES (MEDTRONIC SOFAMOR DANEK). IMPLOANTS USED FOR THE PEEK CAGES WERE FROM A COMPETITOR. ALL PATIENTS WERE FOLLOWED UP RADIOLOGICALLY FOR 24 MONTHS. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: 70 OF 93 LEVELS HAD NONUNION. CYST SIGN, JUST BEFORE SURGERY, THE VERTEBRAL ENDPLATE CYSTS WERE DETECTED AT 7 LEVELS IN THE TI GROUP. CYST FORMATION AND UNION STATUS AT 1 YEAR AFTER SURGERY: 16 NONUNION PATIENTS HAD TRUE POSTIVE, 7 NONUNION PATIENTS HAD FALSE NEGATIVE, CYST FORMATION AND UNION STATUS AT 2 YEAR AFTER SURGERY: 9 NONUNION PATIENTS HAD TRUE POSTIVE, 7 NONUNION PATIENTS HAD FALSE NEGATIVE, THIS REPORT IS FOR A DEVEX CAGE (DEPUY SYNTHES SPINE, RAYNHAM, MA). THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311587 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention