BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 16861322 · Received May 3, 2023

    Report

    Report Number
    9610612-2023-00099
    Event Type
    Injury
    Date Received
    May 3, 2023
    Report Date
    October 2, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    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: BECAUSE WE DID NOT RECEIVE ANY SAMPLE, A THOROUGH INVESTIGATION WAS NOT POSSIBLE. 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: ON THE BASIS OF THE CURRENT INFORMATION A CLEAR CONCLUSION REGARDING THE ROOT CAUSE CANNOT BE DRAWN. AT THIS TIME THERE ARE NO HINTS FOR A PRODUCT RELATED ERROR; IF PRODUCTS ARE RETURNED IN THE FUTURE, ANOTHER INVESTIGATION WILL BE PERFORMED UNSOLICITED. 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. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-SP42 - COLLECT.NO.QAS SPINE ANTERIOR STABILIS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT NEEDED SUPPLEMENTAL FIXATION AT INDEX LEVEL POSTOPERATIVELY, AND RECONSTRUCTION OF DISC. THE FOLLOWING ADVERSE EVENT(S) HAD BEEN REPORTED FROM A SURVEY. PER THE COMPLETED SURVEY, THE FOLLOWING EVENT OCCURRED AT L5-S1 LEVEL WITH SPIKE ENDPLATE. THIS SURVEY WAS A PART OF THE ANNUAL ACTIVL ARTIFICIAL DISC ENHANCED SAFETY SURVEILLANCE STUDY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE(B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00097 (400598774 - AE-QAS-SP42). 9610612-2023-00098 (400598775 - AE-QAS-SP42).

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00097 (400598774 - AE-QAS-SP42); 9610612-2023-00098 (400598775 - AE-QAS-SP42); 9610612-2023-00099 (400598776 - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433205 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. SPINE SURGERY KWQ AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention