BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIF EI H 5MM 4DEG L

    MDR report key: 12287488 · Received August 6, 2021

    Report

    Report Number
    3013730328-2021-00030
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Report Date
    July 8, 2021
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    ODP
    UDI-DI
    04260397080078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART NUMBER: CEI4050L, SYNTHES LOT NUMBER: E20LA1497, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 21 DEC 2020, EXPIRATION DATE: N/A, SUPPLIER: EIT. NO NCRS WERE GENERATED DURING PRODUCTION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. (B)(4). 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENTS CAGE BECAME DISLODGED AFTER IT WAS IMPLANTED. THERE IS NO REVISION SURGERY PLANNED. THE PATIENT IS REPORTED AS GOOD. THIS REPORT INVOLVES ONE (1) CIF EI H 5MM 4DEG L. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187116 CIF EI H 5MM 4DEG L INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP EIT EMERGING IMPLANT TECHNOLOGIES GMBH E20LA1497 04260397080078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention