BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 11068359 · Received December 23, 2020

    Report

    Report Number
    9610612-2020-00942
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    October 30, 2020
    Report Date
    February 23, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED ASSOCIATED MEDWATCH REPORTS IN B5, E1 AND CODES IN H6. 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 THERE IS CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH REPORTS: 9610612-2020-00835 (400491834 - AE-QAS-SP42), 9610612-2020-00945 (400496572 - AE-QAS-SP42).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-SP42 - COLLECT.NO.QAS SPINE ANTERIOR STABILIS. UPON REVIEW OF THE SURVEY FORM, THE SURGEON NOTED THAT THERE WAS A POSSIBLE REVISION OR MIGRATION OF A TOTAL DISC REPLACEMENT (TDR) IN 2019. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00835 ((B)(4) + AE-QAS-SP42), 9610612-2020-00945 ((B)(4) + AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526969 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. SPINE SURGERY KWQ AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 Other