BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE SPINAL MOTION

    MDR report key: 12333352 · Received August 17, 2021

    Report

    Report Number
    9610612-2021-00553
    Event Type
    Injury
    Date Received
    August 17, 2021
    Report Date
    December 16, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    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: 9610612-2021-00540 (400522138 - AE-QAS-SP44). 9610612-2021-00552 (400522402 - AE-QAS-SP44). 9610612-2021-00553 (400522403 - AE-QAS-SP44).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-SP44 - COLLECT.NO.QAS SPINE SPINAL MOTION. ACCORDING TO THE COMPLAINANT, THE IMPLANT EXPERIENCED AN ISSUE WITH "FUNCTION." POST-OPERATIVE IMAGES REVEALED THAT THE IMPLANT WAS IN FLEXION WHERE IT HAS REMAINED SINCE. THE PHYSICIAN ATTRIBUTED THIS TO THE PATIENT'S DIMINISHED, IF NOT ABSENT, MUSCLE TONE IN THE LUMBAR REGION. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER PATIENT INFORMATION HAS BEEN MADE AVAILABLE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00540 (400522138 - AE-QAS-SP44), 9610612-2021-00552 (400522402 - AE-QAS-SP44).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231066 COLLECT.NO.QAS SPINE SPINAL MOTION IMPLANTS SPINAL MOTION KWQ AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other