BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF HI H 12MM 10DEG S

    MDR report key: 12745582 · Received November 3, 2021

    Report

    Report Number
    3013730328-2021-00052
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 7, 2021
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557826652
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. INVESTIGATION SUMMARY: VISUAL INSPECTION: THE ALIF HI H 12MM 10DEG S (PART# AHI31234, LOT# E19CL0071) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE ALIF IMPLANT WAS RETURNED ASSEMBLED WITH THE INSERTER INSTRUMENT (INVESTIGATED SEPARATELY UNDER (B)(4)). THE DEVICES WERE SEIZED AND COULD NOT BE DISASSEMBLED. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE INSTRUMENT WAS SEIZED WITH THE IMPLANT AND COULD NOT BE DISASSEMBLED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DESIGN OF THE DEVICE AND DUE TO THE DEVICES BEING SEIZED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE ALIF HI H 12MM 10DEG S (PART# AHI31234, LOT# E19CL0071). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE 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. DEVICE HISTORY LOT: PART #: AHI31234; LOT #: E19CL0071; SUPPLIER: (B)(4); MANUFACTURING DATE: 5/19/2020; (AS PER THE LOT MASTER). A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE 100673626 NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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

    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. REPORTER IS A J&J SALES REPRESENTATIVE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AFTER IMPLANTATION OF THE CAGE, THE PLACEMENT INSTRUMENT ((B)(4)) COULD NO LONGER BE DETACHED FROM THE IMPLANT ((B)(4)). THE IMPLANT HAD TO BE REMOVED AND A NEW ONE WHICH WAS INSERTED WITH AN ALTERNATIVE PLACEMENT INSTRUMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES DELAY. THIS REPORT IS FOR ONE (1) ALIF HI H 12MM 10DEG S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647867 ALIF HI H 12MM 10DEG S INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH E19CL0071 04260557826652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IMPLANT INSERTER SH CONNECTION.| IMPLANT INSERTER SH CONNECTION