BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLIF-C EI H 9MM 0DEG 32/10

    MDR report key: 9772193 · Received February 28, 2020

    Report

    Report Number
    3013730328-2020-00011
    Event Type
    Injury
    Date Received
    February 28, 2020
    Report Date
    January 29, 2020
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI AND 510K NUMBER ARE UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CONDUIT CAGE. THE CAGE WAS IMPLANTED IN (B)(6) THROUGH A TUBULAR APPROACH AND POSITION WAS CONFIRMED WITH X-RAY. ONE (1) MONTH POSTOPERATIVELY THE IMPLANT WAS REPORTED TO HAVE MIGRATED POSTERIORLY ALONG THE PATH OF INSERTION INTO THE SPINAL CANAL. THE REVISION OF THE IMPLANT TOOK PLACE ON THE (B)(6) 2020. THE REMOVAL WAS PERFORMED WITH THE IMPLANT HOLDER WITHOUT ANY ADDITIONAL CHALLENGES. THE CAGE HAD MIGRATED TO TWO-THIRDS (2/3) OF ITS LENGTH OUTSIDE THE DISC SPACE INTO THE SPINAL CANAL. AFTER REMOVAL AN EXPANDABLE OBLIQUE TLIF FROM ANOTHER MANUFACTURER WAS PLACED AND EXPANDED TO APPROXIMATELY 10MM HEIGHT. THIS REPORT IS FOR A TLIF CONDUIT CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234124 TLIF-C EI H 9MM 0DEG 32/10 INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention