BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIF HI H 7MM 4DEG S

    MDR report key: 15521332 · Received September 30, 2022

    Report

    Report Number
    3013730328-2022-00078
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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. DATE OF EVENT: ONLY THE EVENT YEAR IS KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER OCCCUPATION: REPORTER IS A J&J EMPLOYEE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART# AND LOT # COMBINATION DO NOT MATCH, THEREFORE THE DHR COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED OR THE LOT NUMBER IS CONFIRMED, THE DHR WILL BE REVISITED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE CONDUIT CIF CAGE. AFTER THE SURGERY, THE PATIENT RECEIVED CARE IN THE ICU FOR A POSTOPERATIVE INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CIF HI H 7MM 4DEG S. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384701 CIF HI H 7MM 4DEG S INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP EIT EMERGING IMPLANT TECHNOLOGIES GMBH E20LA0212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention