BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLIF TRIAL INSERTER SH CONNECTION

    MDR report key: 8464192 · Received March 29, 2019

    Report

    Report Number
    3013730328-2019-00032
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    February 28, 2019
    Report Date
    April 4, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557775578
    PMA / PMN Number
    K170503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF INITIAL MANUFACTURER NARRATIVE: 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.

    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.

    Description of Event or Problem · 1

    DURING SURGERY FEATHER KEY OF THE INNER PIN BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260258 TLIF TRIAL INSERTER SH CONNECTION TRIAL INSERTER SH CONNECTION MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH TFT20101 UNKNWON 04260557775578

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention