BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 15513987 · Received September 30, 2022

    Report

    Report Number
    9610612-2022-00267
    Event Type
    Injury
    Date Received
    September 30, 2022
    Report Date
    September 14, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9 - NO PRODUCT RETURN. H6 - CODES UPDATED. . INVESTIGATION: UP TO NOW, THERE ARE NO SAMPLES AVAILABLE, THEREFORE AN INVESTIGATION COULD NOT BE PERFORMED. DEVICE HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. BECAUSE THERE IS NO PRODUCT AVAILABLE FOR ANALYSIS AND NEITHER AN ARTICLE NUMBER NOR A LOT AVAILABLE, A STATISTICAL ANALYSIS IS NOT POSSIBLE. CONCLUSION AND PREVENTIVE MEASURES: ROOT CAUSE CANNOT BE FINALLY CONCLUDED. THEREFORE THE ROOT CAUSE SPECIFIC RISK CANNOT BE IDENTIFIED. THE POTENTIAL RISK DETERMINED DURING INITIAL VIGILANCE EVALUATION REMAINS VALID. A MANUFACTURING OR PRODUCT DEFECT IS UNLIKELY. IF THE PRODUCT IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL AGAIN BE PERFORMED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP AG THAT AN ACTIVL DEVICE (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION DUE TO SUBSIDENCE/MIGRATION OF THE ACTIVL IMPLANT. ADDITIONAL INFORMATION WAS NOT PROVIDED. FURTHER DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00268 (400567625 - AE-QAS-SP42), 9610612-2022-00269 (400567626 - AE-QAS-SP42).

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00267 ((B)(4) - AE-QAS-SP42). 9610612-2022-00268 ((B)(4)- AE-QAS-SP42). 9610612-2022-00269 ((B)(4) - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747964 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. IMPLANTS/DISPOSABLES ANTERIOR KWQ AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention