BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11914319 · Received June 1, 2021

    Report

    Report Number
    1526439-2021-01072
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    January 9, 2009
    Report Date
    May 5, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER/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 THE (B)(6) 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 (1) PLATE AND TRICORTICAL AUTOGRAFT, (2) CAGE, PLATE, AND BONE SUBSTITUTE, (3) CAGE ONLY, AND (4) 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 (B)(6) (RANGE 30¿75 YEARS) , GROUP 2 (CAGE+ PLATE + BONE GRAFT) WITH 15 PATIENTS (9 MALES, 6 FEMALES) AGE (B)(6) (RANGE 24¿ 72 YEARS ), GROUP 3 (CAGE) WITH 15 PATIENTS (8 MALES, 7 FEMALES) AGE (B)(6) (RANGE 34¿76), AND GROUP 4 ( (DISC ARTHROPLASTY) WITH 15 PATIENTS (9 MALES, 6 FEMALES) AGE (B)(6) (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: AT 6 MONTHS, THE FUSION RATE DEMONSTRATED ON X-RAY WAS 84% IN CAGE ONLY GROUP. PAIN POSTOPERATIVELY. IN CAGE ONLY GROUP, ONE PATIENT HAD ASYMPTOMATIC CAGE SUBSIDENCE WHICH WAS FOUND ON X-RAY AT 18 MONTHS, AND IT DID NOT PROGRESS FURTHER AT THE FINAL FOLLOW-UP AT 30 MONTHS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE BRANTIGAN CAGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810944 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention