BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIT TLIF IMPLANT INSERTER

    MDR report key: 8554433 · Received April 26, 2019

    Report

    Report Number
    3013730328-2019-00035
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    September 28, 2017
    Report Date
    September 13, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557775592
    PMA / PMN Number
    K170503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6: NO PATIENT INFORMATION WAS PROVIDED BY THE DISTRIBUTOR. AGE AND WEIGHT WERE BEST ESTIMATED. B5: ADDITIONAL INFORMATION ADDED. H6: ADDITIONAL EVENT PROBLEM AND EVALUATION CODES ADDED. 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.

    Description of Event or Problem · 0

    THE IMPLANT COULD NOT BE RELEASED FROM THE INSERTER. THE INSERTER TOGETHER WITH THE IMPLANT WAS TAKEN OUT OF THE PATIENT. WHEN TRYING TO RELEASE THE IMPLANT FROM THE INSERTER, OUTSIDE OF THE PATIENT, THE INNER SHAFT BROKE. A IMPLANT FROM AN OTHER MANUFACTURER WAS THEN IMPLANTED. EIT GMBH COULD NOT PERFORM ANY INVESTIGATION, AS THE INSTRUMENT IN QUESTION WAS DISCARDED BY THE HOSPITAL AND NO CORRESPONDING IMAGES HAVE BEEN RECEIVED. THE INSTRUMENT ALREADY CONSISTS OF A DESIGNATED BREAKING POINT WHICH IS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND IS ALWAYS ABOVE THE PATIENT'S SKIN. THIS MEASURE WAS IMPLEMENTED AGAINST EXCESSIVE TIGHTENING FORCES AND/OR THREAD FRETTING. AS NO INVESTIGATION RESULTS ARE AVAILABLE DUE TO THE DISCARDED INSTRUMENT, NO ADDITIONAL ACTIONS ARE IMPLEMENTED, AS NO DIFFERENT FAILURE MECHANISM COULD HAVE BEEN DETECTED

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED BY THE DISTRIBUTOR. AGE AND WEIGHT WERE BEST ESTIMATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE IMPLANT COULD NOT BE RELEASED FROM THE INSERTER. THE INSERTER TOGETHER WITH THE IMPLANT WAS TAKEN OUT OF THE PATIENT. WHEN TRYING TO RELEASE THE IMPLANT FROM THE INSERTER, OUTSIDE OF THE PATIENT, THE INNER SHAFT BROKE. A IMPLANT FROM AN OTHER MANUFACTURER WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347822 EIT TLIF IMPLANT INSERTER IMPLANT INSERTER MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH TFT30101 UNKNOWN 04260557775592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization