BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 12260214 · Received August 2, 2021

    Report

    Report Number
    1526439-2021-01596
    Event Type
    Injury
    Date Received
    August 2, 2021
    Report Date
    July 5, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/UNKNOWN LOT. PART AND LOT NUMBER 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OKANO I, ET AL (2020), THE ASSOCIATION BETWEEN ENDPLATE CHANGES AND RISK FOR EARLY SEVERE CAGE SUBSIDENCE AMONG STANDALONE LATERAL LUMBAR INTERBODY FUSION PATIENTS, SPINE, VOLUME 45, NUMBER 23, PAGES E1580-E1587, (USA). THE AIM OF THIS STUDY WAS TO INVESTIGATE THE ASSOCIATION OF MODIC TYPE ENDPLATE CHANGES WITH THE RISK OF SEVERE SUBSIDENCE AFTER STANDALONE LATERAL LUMBAR INTERBODY FUSION (SA-LLIF). FROM 2007 TO 2016, 97 PATIENTS (206 LEVELS) WHO UNDERWENT STANDALONE LATERAL LUMBER INTERBODY FUSION (SA-LLIF) AND HAD PREOPERATIVE COMPUTED TOMOGRAPHY (CT) AND MRI WITHIN 6 MONTHS BEFORE SURGERY, OVER 6 MONTHS OF FOLLOW-UP AND RADIOLOGICAL IMAGING BETWEEN 6 AND 12 MONTHS AFTER SURGERY WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 66.7 YEARS AND 64 OF THE PATIENTS WERE FEMALES. ALL PATIENTS UNDERWENT SA-LLIF UTILIZING EITHER A COMPETITOR¿S SYSTEM OR THE DEPUY SPINE COUGAR SYSTEM. ALL PROCEDURES WERE PERFORMED UTILIZING THE MINI-OPEN SINGLE INCISION TECHNIQUE. AS POTENTIAL CONTRIBUTING FACTORS FOR CAGE SUBSIDENCE, THE ENDPLATE VOLUMETRIC BMD (EP-VBMD) AND THE STANDARD TRABECULAR VOLUMETRIC BMD MEASUREMENT IN THE VERTEBRAL BODY WERE MEASURED. MODIC CHANGES (MC) ON MAGNETIC RESONANCE IMAGING WERE MEASURED AS A QUALITATIVE FACTOR FOR ENDPLATE CONDITION. THE AUTHORS DID NOT SPECIFY WHICH PATIENTS WITH COMPLICATIONS WERE IMPLANTED WITH THE DEPUY SPINE DEVICE. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: 27 PATIENTS (66 LEVELS) HAD SEVERE CAGE SUBSIDENCE. 9 PATIENTS HAD AT LEAST 1 SEVERE SUBSIDENCE LATERAL LUMBER INTERBODY FUSION LEVEL UNDERWENT REVISION SURGERY WITHIN 12 MONTHS THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE COUGAR SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154821 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention