BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

    MDR report key: 16961375 · Received May 19, 2023

    Report

    Report Number
    9610612-2023-00108
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    March 7, 2012
    Report Date
    September 1, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: NO INVESTIGATION METHOD COULD BE APPLIED, BECAUSE PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. DEVICE HISTORY REVIEW: WITHOUT A PROVIDED LOT NUMBER, THE DEVICE QUALITY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THERE IS NEITHER A PRODUCT NOR A PRODUCT CODE AVAILABLE, THEREFORE NO TYPE OF RISK ANALYSIS IS APPLICABLE. EXPLANATION AND RATIONALE: WITHOUT THE PRODUCT, A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. DUE TO THE CONSTANT MONITORING OF THE COMPLIANCE WITH OUR QUALITY STANDARDS, AS MATTERS STAND, A PRODUCTION OR MATERIAL DEFECT CAN MOST LIKELY BE EXCLUDED. CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE PERFORMED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    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 · 0

    ASSOCIATED MEDWATCH-REPORTS: (400599547 - AE-QAS-SP42). 9610612-2023-00109 (400599548 - AE-QAS-SP42). 9610612-2023-00110 (400599549 - AE-QAS-SP42).

    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 WAVE PEEK IMPLANT WAS PLACED IN THE PATIENT AND WHILE THE SURGEON WAS PRESSURE FITTING, THE IMPLANT BROKE. ALL PIECES WERE RETRIEVED FROM THE SURGICAL FIELD VERIFIED BY FLUOROSCOPY. THERE WAS NO HARM TO THE PATIENT. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4)). ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00109 (400599548 - AE-QAS-SP42). 9610612-2023-00110 (400599549 - AE-QAS-SP42).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669677 COLLECT.NO.QAS SPINE ANTERIOR STABILIS. SPINE SURGERY KWQ AESCULAP AG AE-QAS-SP42

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention