BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SPINE

    MDR report key: 11929538 · Received June 3, 2021

    Report

    Report Number
    8030965-2021-04512
    Event Type
    Injury
    Date Received
    June 3, 2021
    Report Date
    May 10, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    ODP
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATES: SPINE/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. 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 THE UNITED KINGDOM AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BHADRA A., RAMAN A., CASEY A., CRAWFORD R., (2009) SINGLE-LEVEL CERVICAL RADICULOPATHY: CLINICAL OUTCOME AND COST-EFFECTIVENESS OF FOUR TECHNIQUES OF ANTERIOR CERVICAL DISCECTOMY AND FUSION AND DISC ARTHROPLASTY, EUR SPINE J VOLUME 18, PAGES 232¿237 (UNITED KINGDOM). THIS STUDY AIMS TO DESCRIBE THE CLINICAL OUTCOME AND COST-EFFECTIVENESS OF FOUR TECHNIQUES FOR SINGLE-LEVEL CERVICAL RADICULOPATHY PLATE AND TRICORTICAL AUTOGRAFT, CAGE, PLATE, AND BONE SUBSTITUTE, CAGE ONLY, AND DISC ARTHROPLASTY. OVER A 5-YEAR PERIOD, SIXTY CONSECUTIVELY TREATED PATIENTS (15 IN EACH GROUP) WITH CERVICAL RADICULOPATHY OWING TO SINGLE-LEVEL DEGENERATIVE DISEASE WERE RECRUITED FOR THE STUDY. THE PATIENTS WERE SYSTEMICALLY ALLOCATED TO ONE OF THE FOUR TECHNIQUES: GROUP 1 (PLATE + AUTOGRAFT) WITH 15 PATIENTS (10 MALES, 5 FEMALES) AGE 35 (RANGE 30¿75 YEARS) , GROUP 2 (CAGE+ PLATE + BONE GRAFT) WITH 15 PATIENTS (9 MALES, 6 FEMALES) AGE 37 (RANGE 24¿ 72 YEARS ), GROUP 3 (CAGE) WITH 15 PATIENTS ( 8 MALES, 7 FEMALES) AGE 38 (RANGE 34¿76), AND GROUP 4 ( (DISC ARTHROPLASTY) WITH 15 PATIENTS ( 9 MALES, 6 FEMALES) AGE 34 (RANGE 30¿68 YEARS ). BRANTIGAN CAGE (DEPUY) IN THE CAGE ONLY GROUP, STANDARD AO PLATE, POLYETHERETHERKETONE CAGE, AND FINE PARTICLES ALLOGRAFT MIXED WITH BLOOD AND MARROW ASPIRATED FROM THE ILIAC CREST IN THE CAGE AND PLATE GROUP AND BRYAN DISC IN THE DISC ARTHROPLASTY GROUP. THE AVERAGE PROSPECTIVE FOLLOW-UP PERIOD WAS 31 MONTHS (RANGE 28¿43 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PLATE AND AUTOGRAFT GROUP (MEAN BLOOD LOSS 100 ML). AT 6 MONTHS, THE FUSION RATE DEMONSTRATED ON X-RAY WAS ONLY 80% IN THE PLATE AND AUTOGRAFT GROUP, 84% IN PLATE AND CAGE GROUP. THIS REPORT IS FOR AN UNKNOWN DEPUY SYNTHES STANDARD AO PLATE . THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829013 UNK - PLATES: SPINE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention