BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIF HI H 16MM 15DEG S

    MDR report key: 15153443 · Received August 2, 2022

    Report

    Report Number
    3013730328-2022-00066
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    July 6, 2022
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557826812
    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. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. OCCUPATION: REPORTER IS A J&J EMPLOYEE. THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE ALIF HI H 16MM 15DEG S, P/N: ALIF HI H 16MM 15DEG S, APPEARS TO BE ASSEMBLED TO THE IMPLANT INSERTER. THE MIGRATION CONDITION CAN NOT BE ASSESSED SINCE NO PATIENT X-RAYS WERE PROVIDED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR ALIF HI H 16MM 15DEG S, P/N: ALIF HI H 16MM 15DEG S. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # AHI51634; LOT # E19LA0523; SUPPLIER: EIT. BATCH1: LOT QTY OF 29 UNITS WERE RELEASED ON 23 SEPT 2019 WITH NO DISCREPANCIES. NO NCRS WERE GENERATED DURING PRODUCTION. THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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.

    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. H10 ADDITIONAL NARRATIVE: A, B5, B7, E, G2, H6: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THEREFORE, PATIENT INFORMATION, MEDICAL HISTORY, EVENT DESCRIPTION, INITIAL REPORTER, REPORT SOURCE AND HEALTH EFFECT - IMPACT CODE HAVE BEEN UPDATED ACCORDINGLY. A1: PATIENT IDENTIFIER: CASE ID #: ID/ CASE #: (B)(4).

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AFTER THE ALIF CAGE WAS PLACED IN THE L5/S1 SEGMENT (ACCESS ANTEROLATERAL FROM THE LEFT), SURGEON REMOVED THE IMPLANT HOLDER FROM THE CAGE. AFTER CONTROL, THE CONDUIT ALIF NEEDED TO BE REPOSITIONED, BECAUSE THE POSITION WAS NOT SATISFACTORY AS PER X-RAY. AGAIN, SURGEON CONNECTED IMPLANT HOLDER TO THE CAGE FOR REPOSITIONING OF THE CAGE. AFTER THIS PROCEDURE THE IMPLANT HOLDER WAS NOT POSSIBLE TO BE REMOVED FROM THE CAGE. IT WAS NO LONGER POSSIBLE TO TURN THE KNOB TO THE RIGHT OR LEFT SIDE (OPEN / CLOSED). SURGEON REMOVED THE CAGE HOLDER AND CONNECTED CAGE FROM THE DISC SPACE L5/S1 AND DID ALTERNATIVE IMPLANTATION OF A TM400 COMPETITOR CAGE. THIS REPORT IS FOR ONE (1) ALIF HI H 16MM 15DEG S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON JULY 6, 2022, AFTER THE ALIF CAGE WAS PLACED IN THE L5/S1 SEGMENT (ACCESS ANTEROLATERAL FROM THE LEFT), SURGEON REMOVED THE IMPLANT HOLDER FROM THE CAGE. AFTER CONTROL, THE CONDUIT ALIF NEEDED TO BE REPOSITIONED, BECAUSE THE POSITION WAS NOT SATISFACTORY AS PER X-RAY. AGAIN, SURGEON CONNECTED IMPLANT HOLDER TO THE CAGE FOR REPOSITIONING OF THE CAGE. AFTER THIS PROCEDURE THE IMPLANT HOLDER WAS NOT POSSIBLE TO BE REMOVED FROM THE CAGE. IT WAS NO LONGER POSSIBLE TO TURN THE KNOB TO THE RIGHT OR LEFT SIDE (OPEN / CLOSED). SURGEON REMOVED THE CAGE HOLDER AND CONNECTED CAGE FROM THE DISC SPACE L5/S1 AND DID ALTERNATIVE IMPLANTATION OF A TM400 COMPETITOR CAGE. THERE WAS A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT OF 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED? THIS REPORT IS FOR ONE (1) ALIF HI H 16MM 15DEG S. THIS IS REPORT 2 OF 2 FOR COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334199 ALIF HI H 16MM 15DEG S INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH E19LA0523 04260557826812

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention IMPLANT INSERTER SH CONNECTION.