BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIT PLIF

    MDR report key: 8460390 · Received March 28, 2019

    Report

    Report Number
    3013730328-2019-00026
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    December 14, 2017
    Report Date
    April 4, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF ADDITIONAL MANUFACTURER NARRATIVE: OMA/510K: 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. 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. 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.

    Description of Event or Problem · 1

    FIRST SURGERY WAS PERFORMED ON (B)(6) 2017 WHEN THE SURGEON USED ALEUTIAN GEN 2 PARALLEL CAMS TO DILATE, EIT SHAVERS, POST PREP INSTRUMENTS TO PREPARE, EIT BLOCK TRIAL TO SIZE SPACE, INSERT AND ROTATE TECHNIQUE FOR CAGE. BASED ON THE PROVIDED INFORMATION, IT IS ASSUMED THAT TWO PLIF CAGES WERE IMPLANTED. HOWEVER THIS IS NOT CONFIRMED. OPERATED LEVEL IS L5/S1. RECEIVED INFORMATION SAYS THAT "CAGE WAS DISPLACED AND REVISED WITHIN THE WEEK ON (B)(6) 2018. ACCORDING TO RECEIVED INFORMATION "SURGEON BELIEVED TECHNICAL AREA NOT IMPLANT RELATED". THIS STATEMENT IS NOT CLEAR TO EIT AND THEREFORE WILL BE HANDLED AGAIN DURING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251995 EIT PLIF PLIF CAGE, H: 8MM, 6°, 22MM X 9MM MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH PEI60802 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention