BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIT ALIF

    MDR report key: 8463877 · Received March 29, 2019

    Report

    Report Number
    3013730328-2019-00031
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Report Date
    September 13, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6. NO FURTHER PATIENT INFORMATION WAS PROVIDED BY COMPLAINANT. AGE AND WEIGHT ARE BEST ESTIMATED. NO ADDITIONAL DATA HAS BEEN ADDED. EIT HAS CLOSED THE INVESTIGATION AND CLOSED THE COMPLAINT. EIT EMERGING IMPLANT TECHNOLOGIES GMBH (EIT) IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH EIT HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, EIT OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, EIT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PER CAPA 2018-AUD-010 DRIVEN BY AN AUDIT, PERFORMED BY THE PARENT COMPANY JOHNSON & JOHNSON, IT WAS EVALUATED THAT THE COMPLAINT/INCIDENT ON HAND NEEDS TO BE REPORTED RETROSPECTIVELY.

    Description of Event or Problem · 0

    TRIAL INSERTER PIN BROKE DUE TO TOO HIGH TORQUE APPLIED TO THE KNOB. PART OF INSERTER PIN IS STUCK IN TRIAL.

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED BY COMPLAINANT. AGE AND WEIGHT ARE BEST ESTIMATED. EIT EMERGING IMPLANT TECHNOLOGIES (B)(4) (EIT) IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH EIT HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PER CAPA (B)(4) DRIVEN BY AN AUDIT, PERFORMED BY THE PARENT COMPANY JOHNSON & JOHNSON, IT WAS EVALUATED THAT THE COMPLAINT/INCIDENT ON HAND NEEDS TO BE REPORTED RETROSPECTIVELY.

    Description of Event or Problem · 1

    TRIAL INSERTER PIN BROKE DUE TO TOO HIGH TORQUE APPLIED TO THE KNOB. PART OF INSERTER PIN IS STUCK IN TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256276 EIT ALIF EIT ALIF TRIAL INSERTER MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH AET20101 E16DI0203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other