BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 12333525 · Received August 17, 2021

    Report

    Report Number
    9610612-2021-00546
    Event Type
    Injury
    Date Received
    August 17, 2021
    Report Date
    April 7, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    MDM
    Adverse Event
    Yes
    Product Problem
    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: 9610612-2021-00546 ((B)(6) - AE-QAS-SP42). 9610612-2021-00564 ((B)(6) - AE-QAS-SP42). 9610612-2021-00565 ((B)(6) - AE-QAS-SP42).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. A GENERAL CODE WAS USED, AS WE CANNOT IDENTIFY A PRODUCT CODE FOR AN UNKNOWN DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP INC. ON AN ESS SURGEON ACTIVEL SURVEY (REPORTING DURING THE TIME FRAME 1FEB2020 TO 31JAN2021), UNSPECIFIED ACTIVEL WAS USED DURING A TOTAL DISC REPLACEMENT (TDR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINT DESCRIPTION, AN ADVERSE EVENT WAS REPORTED. THE ACTUAL PATIENT HARM IS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00546 ((B)(4)- AE-QAS-SP42). 9610612-2021-00564 ((B)(4)- AE-QAS-SP42). 9610612-2021-00565 ((B)(4)- AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231838 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. IMPLANTS/DISPOSABLES ANTERIOR MDM AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other