BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ´

    MDR report key: 12407776 · Received September 1, 2021

    Report

    Report Number
    9610612-2021-00589
    Event Type
    Injury
    Date Received
    September 1, 2021
    Report Date
    December 7, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. ON AN ESS ACTIVEL SURGEON SURGERY UNSPECIFIED ACTIVEL WAS USED DURING A TOTAL DISC REPLACEMENT (TDR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SURGEON REPORTED A SENSORY NEUROLOGICAL EVENT PRESUMABLY IN ONE PATIENT IMPLANTED AT L4-L5 WITH THE ACTIVL SPIKE ENDPLATE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00588 ((B)(4) - AE-QAS-SP42). 9610612-2021-00590 ((B)(4) - AE-QAS-SP42).

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00588 (400524362 - AE-QAS-SP42). 9610612-2021-00589 (400524477 - AE-QAS-SP42). 9610612-2021-00590 (400524478 - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302170 ´ IMPLANTS/DISPOSABLES ANTERIOR KWQ AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other