BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACER: CONCORDE

    MDR report key: 13670765 · Received March 4, 2022

    Report

    Report Number
    1526439-2022-00338
    Event Type
    Injury
    Date Received
    March 4, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: THIS REPORT IS FOR AN UNK - CAGE/SPACER: CONCORDE/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. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LYNCH, C.P. ET AL. (2021), OUTCOMES OF TRANSFORAMINAL LUMBAR INTERBODY FUSION USING UNILATERAL VERSUS BILATERAL INTERBODY CAGES, NEUROSPINE, VOL. 18(4), PAGES 854-862 (USA) THE OBJECTIVE OF THIS STUDY IS TO ASSESS THE IMPACT OF BILATERAL VERSUS UNILATERAL INTERBODY CAGES ON OUTCOMES FOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) PROCEDURES. FROM 2008¿2020, 151 PATIENTS, WITH 111 UNILATERAL AND 40 BILATERAL CAGE PLACEMENTS UNDERWENT SINGLE-LEVEL MIS TLIF PROCEDURES WITH BILATERAL POSTERIOR INSTRUMENTATION USING T-PAL AND CONCORDE CAGES (DEPUY SYNTHES, RAYNHAM, MA, USA) FOR INTERBODY CAGES. THE COHORT¿S MEAN AGE WAS 52.1 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 12 PATIENTS HAD NONUNION WHO UNDERWENT INDEX-LEVEL REVISION PROCEDURES. ALL PATIENTS WITH RADIOGRAPHICALLY CONFIRMED PSEUDOARTHROSIS SUBSEQUENTLY UNDERWENT REVISION PROCEDURES. OF THESE PATIENTS WITH PSEUDOARTHROSIS, 3 DEMONSTRATED SIGNIFICANT CONCOMITANT SUBSIDENCE. THIS REPORT IS FOR AN UNKNOW SYNTHES CONCORDE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE (1) UNK - CAGE/SPACER: CONCORDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964086 UNK - CAGE/SPACER: CONCORDE INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention