BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIS PROTI COM/L5 MM H

    MDR report key: 12066666 · Received June 25, 2021

    Report

    Report Number
    3012966183-2021-00015
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 25, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    ODP
    UDI-DI
    00819917020564
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE HISTORICAL DATA REVIEW AND THE DEVICE HISTORY RECORD REVIEW THERE WERE NO TRENDS OBSERVED WITH THIS COMPLAINT TYPE. THERE WERE NO NON-CONFORMANCES OR CAPAS ASSOCIATED WITH THE LOT OR PART NUMBER. THE SURGICAL TECHNIQUE AND DEVICE SPECIFICATIONS WERE ALSO REVIEWED FOR THIS INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED AND FURTHER INFORMATION WITH REGARDS TO THIS CASE WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION THE ROOT CAUSE IS INDETERMINATE.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED THE CERVICAL CAGE WITH THE PLUNGER FROM THE ACIS SET. THE CAGE BROKE ON THE BACKSIDE. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR GREATER THAN 20 MINUTES., DEVICE WAS EXPLANTED AND A REPLACED WITH A NEW DEVICE. PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED., FRAGMENTS WERE REPORTED AS BEING GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965480 ACIS PROTI COM/L5 MM H NTERBODY - ACIS ODP TYBER MEDICAL 108843505 166116 00819917020564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other