BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD® 2.0

    MDR report key: 23932642 · Received December 31, 2025

    Report

    Report Number
    3010673777-2025-00044
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 31, 2025
    Manufacturer
    NOVASTEP SAS
    Product Code
    JDR
    UDI-DI
    03700879516554
    PMA / PMN Number
    K230724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON RECOMMENDED A FOUR-WEEK PERIOD OF NON-WEIGHT BEARING, WHICH IS CONSIDERED AN AGGRESSIVE DURATION. FURTHER INVESTIGATION IS NOT POSSIBLE DUE TO A LACK OF ADDITIONAL INFORMATION REGARDING THIS CASE.

    Description of Event or Problem · 0

    WE WERE INFORMED ON THE (B)(6) 2025. THAT 4 BROKEN COMPRESSIVE STAPLE QUADRO 30X16X16X14X12, WITH NO ACCOMPANYING INVESTIGATIONS OR FURTHER CASE INFORMATION. NO BATCH NUMBERS WERE AVAILABLE, AS THE PRODUCTS HAD BEEN DISCARDED, NO DATES HAVE BEEN COMMUNICATED OR FURTHER INFORMATION ABOUT THESE CASES. IT SEEMS LIKE ONE OR MORE REVISION SURGERIES WERE PERFORMED THIS WAS NOT CONFIRMED AND WE ARE UNABLE TO HAVE FURTHER INFORMATION REGARDING THESE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2548813 ARCAD® 2.0 COMPRESSIVE STAPLE QUADRO 30X16X16X14X12 JDR NOVASTEP SAS CSK301612 NOT COMMUNICATED 03700879516554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other