BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF HI H 8MM 5DEG L

    MDR report key: 13227983 · Received January 11, 2022

    Report

    Report Number
    3013730328-2022-00010
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 11, 2021
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557772751
    PMA / PMN Number
    K172888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: 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.

    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: H6: NO VALID LOT NUMBER WAS PROVIDED OR FOUND IN THE PHOTOS, THEREFORE NO DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED. THE DHR REVIEW WILL BE REVISITED IF A VALID LOT NUMBER IS PROVIDED OR THE PHYSICAL DEVICE IS RECEIVED. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE RECEIVED IMAGE. THE IMAGE WAS REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS THE ASTERISK IS MISSING. HOWEVER, THIS IS DUE TO THE US TECHNIQUE GUIDE BEING USED INSTEAD OF THE GERMAN TECHNIQUE GUIDE. THE GERMAN TECHNIQUE GUIDE CORRECTLY HAS THE ASTERISK. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE PROVIDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGE) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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) 2021, THE INSTRUCTIONS FOR USE (IFU) FOR THE CONDUIT ALIF IMPLANTS MARKS THE IMPLANTS WHICH ONLY HAVE THE ANTERIOR INSERTER INTERFACE CONNECTION WITH A FOOTNOTE SYMBOL. FOR A SURGERY THE SURGEON SELECTED A SIZE L 8MM 5° IMPLANT BECAUSE THE IFU SHOWS THE IMPLANT WITHOUT A FOOTNOTE SYMBOL. THE SURGEON STATES THAT THIS IMPLANT SHOULD ALSO HAVE THE LATERAL INSERTER INTERFACE. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE IMPLANT. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THIS REPORT INVOLVES ONE (1) EIT ALIF, H 8MM, 5°, L. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243236 ALIF HI H 8MM 5DEG L INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH AUI10840 04260557772751

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown