BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROADBAND LOOP

    MDR report key: 17756818 · Received September 15, 2023

    Report

    Report Number
    3006981798-2023-00055
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    July 24, 2023
    Report Date
    November 1, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    00810020081237
    PMA / PMN Number
    K190817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND THEREFORE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. INVESTIGATION IS STILL ONGOING. NO CAUSE FOR THE EVENT HAS BEEN ESTABLISHED AT THIS TIME. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 0

    REVIEW OF STERILIZATION RECORDS SHOWED THAT ALL PRODUCTS MET STERILIZATION REQUIREMENTS PRIOR TO RELEASE. RETAIN SAMPLES WERE PULLED AND UNDERWENT THIRD-PARTY STERILITY TESTING. THE SAMPLES TESTED WERE FOUND TO BE NEGATIVE FOR GROWTH AFTER 14 DAYS INCUBATION. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER REPLACEMENT ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 TO EXCHANGE THE HUMERAL BEARING, GLENOSPHERE, AND TAPER ADAPTER. THERE WAS A CONTINUATION OF THE EVENT WHERE THERE WAS CONTINUOUS WOUND OOZE, SO ALL IMPLANTS WERE REMOVED ON (B)(6) 2023."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290349 BROADBAND LOOP NONABSORBABLE SURGICAL SUTURE GAT RIVERPOINT MEDICAL LLC CM-0323N 22030419 00810020081237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention