BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LORENZ LARYNGEAL PROSTHESIS 7MM

    MDR report key: 7189211 · Received January 15, 2018

    Report

    Report Number
    0001032347-2018-00031
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    January 3, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    FWN
    PMA / PMN Number
    PK896667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: FWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "THE 7 MM COTTON MEYER STENT WAS TO THICK. THE SURGEON STRUGGLED FOR OVER AN HOUR AND FINALLY HAD TO USE THE 7.5 COTTON MEYER. THE CASE HAS BEEN EXTENDED NOW AND EXPOSED THE CHILD TO LONGER THEN PLANNED ANESTHESIA. THE HOLE IN THE CENTER OF THE STENT IS TOO NARROW FOR THE SURGEON TO INSERT INSTRUMENTATION. ANOTHER SURGEON STEPPED IN TO ASSIST IN THE CASE AND THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY USING A NEW STENT AND PLACING THE INSTRUMENTATION ANTERIOR TO THE STENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AND HAS BEEN DISCHARGED FROM THE HOSPITAL." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33825 COTTON-LORENZ LARYNGEAL PROSTHESIS 7MM STENT FWN BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention