BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIT TLIF IMPLANT INSERTER

    MDR report key: 8459061 · Received March 28, 2019

    Report

    Report Number
    3013730328-2019-00014
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    February 5, 2018
    Report Date
    April 4, 2019
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF ADDITIONAL MANUFACTURER NARRATIVE: NO PATIENT INFORMATION WAS PROVIDED BY THE DISTRIBUTOR. AGE AND WEIGHT WERE BEST ESTIMATED. RECALL. EIT GMBH HAS RECALLED ALL DEVICES TET30100 AND TET30101. RECALL WAS INITIATED JULY 25, 2018, AND CLOSED BY FEBRUARY 20, 2019. THE INSTRUMENTS ARE NOW REPLACED BY THEIR SUCCESSOR MODELS TFT30101 AND TFT30100. PRODUCT IS NOT CLEARED FOR US MARKET. 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. 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.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED BY THE DISTRIBUTOR. AGE AND WEIGHT WERE BEST ESTIMATED. RECALL. EIT (B)(4) HAS RECALLED ALL DEVICES TET30100 AND TET30101. RECALL WAS INITIATED JULY 25, 2018, AND CLOSED BY FEBRUARY 20, 2019. THE INSTRUMENTS ARE NOW REPLACED BY THEIR SUCCESSOR MODELS TFT30101 AND TFT30100. PRODUCT IS NOT CLEARED FOR US MARKET. 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.

    Description of Event or Problem · 1

    DURING SURGERY, THE T-PART OF THE INSERTER PIN BROKE DURING IMPACTION OF THE TLIF CAGE. THE REAR PART OF THE CAGE WAS OUTSIDE OF THE DISC SPACE AND IT WAS POSSIBLE TO REMOVE THE BROKEN PART. THE IMPACTION WAS CONTINUED WITH THE IMPACTOR TET30200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255754 EIT TLIF IMPLANT INSERTER IMPLANT INSERTER MAX TET30100 E15DI0130

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization