BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIT PLIF CAGE

    MDR report key: 8460219 · Received March 28, 2019

    Report

    Report Number
    3013730328-2019-00023
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    February 15, 2018
    Report Date
    April 4, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF ADDITIONAL MANUFACTURER NARRATIVE: PMA/510K: DEVICE NOT MARKETED IN THE US. BUT A 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 PATIENT INFORMATION WERE PROVIDED BY THE COMPLAINANT. AGE AND WEIGHT WERE BEST ESTIMATED. DEVICE NOT MARKETED IN THE US. BUT A SIMILAR DEVICE IS MARKETED. EIT EMERGING IMPLANT TECHNOLOGIES (B)(4) (EIT) IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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

    THE EIT CAGES PEI31206 WERE IMPLANTED IN LEVEL L3/L4 ON (B)(6) 2017. WHEN EXAMINING THE PATIENT IN HIS POST SURGERY CONSULTATION, THE SURGEON NOTICED BOTH CAGES HAD MOVED POSTERIORLY AND THE RIGHT SIDED CAGE ALSO ROTATED AND MOVED MEDIALLY CAUSING RIGHT BUTTOCK PAIN FOR THE PATIENT. BOTH CAGES THEREFORE WERE REMOVED ON (B)(6) 2017 AND REPLACED WITH TWO PLIF CAGES PEI91310, PLIF CAGE H13MM, 30/9, 18°. EXPLANTS WERE DISCARDED AND THEREFORE COULD NOT BE RETURNED TO EIT FOR INVESTIGATION. THE PATIENT WAS REVISED ON (B)(6) 2018 FOR REPOSITIONING OF PEDICLE SCREWS. IN THIS REVISION IT WAS NOTED THAT THE 18° CAGES HAD ALSO MIGRATED POSTERIORLY. THE SURGEON DECIDED TO IMPACT THESE FURTHER INTO THE DISC SPACE INSTEAD OF REMOVING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251961 EIT PLIF CAGE PEI31206 MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH PEI31206 NO INFORMATION RECEIVED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization