BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 12397383 · Received August 31, 2021

    Report

    Report Number
    9610612-2021-00594
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    December 15, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00528 (400524761 - AE-QAS-SP42). 9610612-2021-00593 (400524897 - AE-QAS-SP42). 9610612-2021-00594 (400524898 - AE-QAS-SP42).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP INC. ON AN ENHANCED SAFETY SURVEILLANCE (ESS) SURGEON SURVEY THAT AN UNSPECIFIED ACTIVEL WAS IMPLANTED DURING A TOTAL DISC REPLACEMENT (TDR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SURGEON REPORTED A "SENSORY NEUROLOGICAL" SAFETY EVENT EXPERIENCED BY A PATIENT IMPLANTED AT L4-L5 WITH THE ACTIVL SPIKE ENDPLATE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00528 (400524761 - AE-QAS-SP42), 9610612-2021-00593 (400524897 - AE-QAS-SP42), 9610612-2021-00594 (400524898 - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293572 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. SPINE SURGERY KWQ AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other