BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AE-QAS-SP42

    MDR report key: 18826355 · Received March 4, 2024

    Report

    Report Number
    2916714-2024-00016
    Event Type
    Injury
    Date Received
    March 4, 2024
    Report Date
    March 13, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    KWG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC., VIA THE ANNUAL ACTIVL ENHANCED SAFETY SURVEILLANCE STUDY (ESS) COVERING A REPORTING PERIOD FROM 01FEB2023 TO 31DEC2023, THAT AN UNKNOWN ACTIV L DEVICE WAS IMPLANTED ON (B)(6) 2023 AT THE L4-5 LEVEL. ACCORDING TO THE COMPLAINANT THE PATIENT EXPERIENCED A SENSORY NEUROLOGICAL EVENT ON AN UNSPECIFIED DATE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORTS. 2916714-2024-00015 2916714-2024-00017 2916714-2024-00018 2916714-2024-00019 2916714-2024-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194848 AE-QAS-SP42 IMPLANTS/DISPOSABLES ANTERIOR KWG AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other