BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECT.NO.QAS SPINE SPINAL MOTION

    MDR report key: 8701827 · Received June 14, 2019

    Report

    Report Number
    9610612-2019-00402
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 17, 2019
    Report Date
    August 5, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    MJO
    PMA / PMN Number
    P120024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION : NO PRODUCT AT HAND. THEREFORE AN INVESTIGATION IS NOT POSSIBLE. THERE ARE NO PICTURES AVAILABLE. BATCH HISTORY REVIEW : BECAUSE THE LOT NUMBER IS UNKNOWN, A BATCH HISTORY REVIEW IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE : DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVE THE COMPLAINED DEVICES FOR INVESTIGATION AND LACK OF INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE CONCLUSION AND ROOT CAUSE FOR THE MENTIONED FAILURE. RATIONALE : BECAUSE THERE ARE NO PRODUCTS AND ONLY MINOR INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE ANALYSIS IS NOT POSSIBLE. FOLLOWING CAUSES ARE POSSIBLE: WRONG SYSTEM CONFIGURATION SELECTED BY USER; WRONG IMPLANT SIZE CHOSEN BY USER; END PLATE FORMED TOO STRONG; DESIGN LAYOUT UNSUITABLE; INADEQUATE PATIENT BEHAVIOR. NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ACTIVL ARTIFICIAL DISC SYSTEM. THE IMPLANTS CONSIST OF 3 COMPONENTS THAT ARE PUT TOGETHER. IT WAS REPORTED VIA THE ENHANCED SAFETY SURVEILLANCE SURVEY THAT THE A DEVICE DIS-ASSEMBLED DURING SURGERY IN ONE INSTANCE. THE SURGEON NOTED THAT THE INSERTION TOOLS NEEDED MORE SECURE FIXATION TO THE DEVICE. THIS REPORT WAS A CUMULATIVE REVIEW OF THE DEVICES BASED ON THE SURGEON'S 1-2 YEAR EXPERIENCE USING THE IMPLANT SYSTEM AND WAS RELEVANT FROM 01FEB2018- 31JAN2019 TIMEFRAME. THE SURGEON HAS REPORTEDLY PERFORMED A TOTAL OF 12 SURGERIES; FIVE PROCEDURES AT L4-L5, FOUR PROCEDURES AT L5-S1, AND TWELVE PROCEDURES USING SPIKE ENDPLATES. THE REPORTER STATED THAT PATIENTS WHO HAVE BEEN IMPLANTED WITH THE ACTIVL ARTIFICIAL DISC SYSTEM DID NOT REQUIRE MORE THAN A STANDARD PAIN MEDICINE PROTOCOL POST-SURGERY; THAT STANDARD PAIN MANAGEMENT CONSISTED OF PHYSICAL THERAPY. IT WAS ADDITIONALLY NOTED THAT THERE HAVE BEEN NO OTHER SAFETY CONCERNS; THE PHYSICIAN STATED THAT L5-S1 PROCEDURES SHOWED BETTER OUTCOMES THAN L4-L5. OVERALL, PATIENT OUTCOMES FOLLOWING ACTIVL ARTIFICIAL DISC IMPLANTATION SHOWED IMPROVED RANGE OF MOTION, STABILITY, AND NEUROLOGICAL STATUS. THEY ALSO EXPERIENCED IMPROVED BACK PAIN RELIEF AND IMPROVED DISABILITY AND THAT PATIENTS RETURN TO WORK WITHIN THE EXPECTED TIMEFRAME MOST OF THE TIME. INTERVENTION WAS NOT REQUIRED AND NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492315 COLLECT.NO.QAS SPINE SPINAL MOTION SPINE SURGERY MJO AESCULAP AG AE-QAS-SP44

    Patients

    Seq Age Sex Outcome Treatment
    1