BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11958248 · Received June 8, 2021

    Report

    Report Number
    1526439-2021-01183
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    March 1, 2010
    Report Date
    May 14, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    OVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. DEVICE AVAILABLE FOR EVALUATION: 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: BARTELS R., ET AL (2010) THE RATIONALE OF POSTOPERATIVE RADIOGRAPHS AFTER CERVICAL ANTERIOR DISCECTOMY WITH STAND-ALONE CAGE FOR RADICULAR PAIN, J NEUROSURG SPINE VOLUME 12, PAGES 275¿279 (NETHERLAND) DOI: 10.3171/2009.9.SPINE09263). THIS STUDY AIMS TO EVALUATE WHETHER POSTOPERATIVE PLAIN RADIOGRAPHS INFLUENCED THE MEDICAL OR SURGICAL TREATMENT OF PATIENTS WHO UNDERWENT CERVICAL ANTERIOR DISCECTOMY WITH STAND-ALONE CAGE (CADC) PLACEMENT. IN 2007, 82 PATIENTS (41 WOMEN AND 41 MEN) UNDERWENT CADC PLACEMENT FOR RADICULAR PAIN DUE TO A HERNIATED DISC WITH A MEAN AGE OF 49.3 ± 9.5 YEARS (RANGE 30.5¿ 75.1 YEARS). THE CHARTS AND RADIOGRAPHS OF THESE PATIENTS WERE RETRIEVED AND REVIEWED RETROSPECTIVELY. TWO SIZES OF CAGES (CERVICAL INTERBODY FUSION CAGES, DEPUY SPINE, JOHNSON & JOHNSON) ARE AVAILABLE; 115 IMPLANTED CAGES WERE LARGE AND 23 WERE STANDARD. A TOTAL OF 185 RADIOGRAPHIC EXAMINATIONS WERE PERFORMED AT 3 POSTOPERATIVE INTERVALS. THE SAME ITEMS AS IN THE RETROSPECTIVE STUDY THE CHARTS AND RADIOGRAPHS OF 50 CONSECUTIVE PATIENTS (29 WOMEN, 31 MEN) WITH A MEAN AGE OF 49.9 ± 8.4 YEARS (RANGE 32.9¿62.4 YEARS) WHO WERE SEEN AFTER A CADC WAS PLACED BETWEEN AUGUST 1, 2008, AND NOVEMBER 1, 2008 WERE STUDIED PROSPECTIVELY. OF THESE CAGES (CERVICAL INTERBODY FUSION CAGES, DEPUY SPINE, JOHNSON & JOHNSON), 66 WERE LARGE AND 9 WERE STANDARD. RADIOGRAPHS WERE OBTAINED AT THE FOLLOWING TIME POINTS: 1 DAY POSTOPERATIVELY (IN 19 PATIENTS), 6 WEEKS POSTOPERATIVELY (IN 22 PATIENTS), 3 MONTHS POSTOPERATIVELY (IN 4 PATIENTS), 6 MONTHS POSTOPERATIVELY (IN 4 PATIENTS), AND IN 1 PATIENT 5 YEARS AFTER THE SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SUBSIDENCE WAS SEEN IN 20 LEVELS (14.5% OF ALL LEVELS) IN PATIENTS IN THE RETROSPECTIVE STUDY, AND IT WAS NOT RELATED TO THE SIZE OF THE CAGE. THIS WAS NOTED ON THE RADIOGRAPHS OBTAINED 6 WEEKS POSTOPERATIVELY. THE ONLY ABNORMALITY SEEN ON THE RADIOGRAPHS WAS SUBSIDENCE AT THE OPERATING LEVEL IN 8 PATIENTS IN THE PROSPECTIVE STUDY. IN 1 PATIENT A SLIGHT ANTEROPOSITION OF THE CAGE WAS SEEN. (SLIGHT ANTERIOR CAGE POSITIONING). POOR RESULT ACCORDING TO ODOM CRITERIA. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CERVICAL INTERBODY FUSION CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856491 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1