BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE SPINAL MOTION

    MDR report key: 12333351 · Received August 17, 2021

    Report

    Report Number
    9610612-2021-00540
    Event Type
    Injury
    Date Received
    August 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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), 9610612-2021-00553 (400522403 - AE-QAS-SP44)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231062 COLLECT.NO.QAS SPINE SPINAL MOTION IMPLANTS SPINAL MOTION KWQ AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other