BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 12359982 · Received August 24, 2021

    Report

    Report Number
    9610612-2021-00576
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Report Date
    December 7, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    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: 9610612-2021-00579 ((B)(6) - AE-QAS-SP42), 9610612-2021-00580 ((B)(6) - AE-QAS-SP42), AND 9610612-2021-00576 ((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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH (B)(4) COLLECT NO. QAS SPINE ANTERIOR STABILIS. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS AN ISSUE WITH ACTIVL IMPLANT POST SURGERY. THE ORIGINAL PROCEDURE WAS A LUMBAR TOTAL DISC ARTHROPLASTY OF L5-S1 IN (B)(6) 2020. THE PATIENT IS STILL HAVING OCCASIONAL NEUROPATHY AND MILD LOW BACK PAIN. THERE WAS A TEMPORARY IMPAIRMENT. THE PATIENT HAD REPEAT IMAGING STUDIES DUE TO THE PAIN; INITIALLY THE IMPLANT POSITIONING WAS GOOD AND OTHER SURROUNDING STRUCTURES WERE NORMAL. THE PATIENT DID NOT EXPERIENCE TRAUMA OR FALL. ON (B)(6), RESULTS OF COMPUTED TOMOGRAPHY (CT) MYELOGRAM SHOWED INTERVAL DEVELOPMENT OF BILATERAL L5 PARS DEFECTS AND RIGHT L5 LAMINAR FRACTURE, WITHOUT SPONDYLOLITHESIS. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00579 (400523620 - AE-QAS-SP42), 9610612-2021-00580 (400523621 - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257620 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. IMPLANTS/DISPOSABLES ANTERIOR KWQ AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male