BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIT TLIF

    MDR report key: 8463871 · Received March 29, 2019

    Report

    Report Number
    3013730328-2019-00029
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    December 7, 2018
    Report Date
    July 23, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6. NO FURTHER PATIENT INFORMATION WAS PROVIDED BY COMPLAINANT. AGE AND WEIGHT ARE BEST ESTIMATED. G5: DEVICE NOT MARKETED IN US, BUT SIMILAR DEVICE IS MARKETED. 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

    INSTRUMENT BROKE DURING USE DUE TO A TOO HIGH APPLIED TORQUE ON THE KNOB. TIP OF INSERTER PIN BROKE OFF.

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED BY COMPLAINANT. AGE AND WEIGHT ARE BEST ESTIMATED. DEVICE NOT MARKETED IN US, BUT SIMILAR DEVICE IS MARKETED. 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

    INSTRUMENT BROKE DURING USE DUE TO A TOO HIGH APPLIED TORQUE ON THE KNOB. TIP OF INSERTER PIN BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256285 EIT TLIF EIT TLIF TRIAL INSERTER MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH TET20100 E16DI0151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other