BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: SYNCAGE

    MDR report key: 10817672 · Received November 10, 2020

    Report

    Report Number
    8030965-2020-08816
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    October 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN SYNCAGE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: KREUSCH-BRINKER, R. (2010), THE USE OF SYNCAGES FOR ANTERIOR SPINE FUSION, EUROPEAN SPINE JOURNAL, VOL. 19, PAGE 2019, HTTPS://DOI.ORG/10.1007/S00586-010-1601-9 (GERMANY). THE AIM OF THIS STUDY IS TO PRESENT THE USE OF SYNCAGES FOR ANTERIOR SPINE FUSION. BETWEEN 1999 TO 2000, A TOTAL OF 38 PATIENTS WERE IMPLANTED WITH A TOTAL OF 44 CAGES FILLED WITH AUTOLOGOUS BONE GRAFT EITHER FROM THE ILIAC CREST OR FROM THE REMOVED VERTEBRAL ARCH IN COMBINATION OF AN USS FIXATEUR. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 6 CASES SHOWED A PRIMARILY PERIPHERAL PLACEMENT OF THE CAGE WITH INCOMPLETE FUSION. THIS REPORT IS FOR AN UNKNOWN SYNTHES SYNCAGE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283013 UNK - CAGE/SPACERS: SYNCAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention