BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIF EI H 5MM 4DEG L

    MDR report key: 14168242 · Received April 21, 2022

    Report

    Report Number
    3013730328-2022-00034
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 23, 2022
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    ODP
    UDI-DI
    04260397080078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. 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. 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: H3, H4, H6 INVESTIGATION SUMMARY THE PHOTOS WERE RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM FORWARDED THE EVIDENCE TO "EIT EMERGING IMPLANT TECHNOLOGIES", WHICH CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE PHOTOS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE FROM ATTACHMENT. VISUAL ANALYSIS OF THE RETURNED SAMPLE WAS PERFORMED ON CIF EI H 5MM 4DEG L (P/N: CEI4050L, LOT: E20CL0433). IT WAS IDENTIFIED THAT THE DEVICE WAS MIGRATED FROM THE ORIGINAL POSITION THAT WAS IMPLANTED. NO OTHER ISSUE COULD BE IDENTIFIED. VISUAL ANALYSIS OF THE RETURNED SAMPLE WAS PERFORMED ON CIF EI H 5MM 4DEG L (P/N: CEI4050L, LOT: E20CL0433) BY THE SUPPLIER WHERE IT IS ESTABLISHED THAT: THE LOT E20CL0433 WAS MANUFACTURED BY THE EXTERNAL SERVICE MANUFACTURER, BEING 3DSYSTEMLAYERWISE (SEE ATTACHMENTS #3 TO #5). IT WAS NOTICED THAT THE SELECTIVE LASER MELTING (SLM) MANUFACTURING PROCESS WAS PERFORMED WITH INCORRECT LASER POWER PARAMETER. THE ISSUE WAS INVESTIGATED BY EIT WITH NCMR 2020-138. THE NCMR CONCLUDED THAT THE DEVICES CAN BE RELEASED WITH A USED-AS-IS DECISION, AFTER ADEQUATE MECHANICAL PERFORMANCE COULD BE CONFIRMED. THE INSPECTION OF THE IMPLANTS PERFORMED BY 3D SYSTEMS AS WELL AS THE INCOMING INSPECTION PERFORMED BY EIT (WERE SUCCESSFULLY PERFORMED AND DO NOT SHOW ANY CONSPICUOUS FEATURES/TOPICS. AFTER SUCCESSFUL INSPECTION OF THE IMPLANTS AT EIT THEY HAVE BEEN FINAL CLEANED, PACKAGED AND STERILIZED AT THE EXTERNAL SERVICE PROVIDER BEING STERIPAC GMBH. THE MANUFACTURING DOCUMENTATION PROVIDED BY STERIPAC DOES NOT SHOW ANY CONSPICUOUS FEATURES/TOPICS. AFTER STERILIZATION THE PACKAGED DEVICES HAVE BEEN SUCCESSFULLY INSPECTED ANOTHER TIME BY EIT. EIT NOT AWARE OF ANY OTHER COMPLAINT MENTIONING THAT BONE GRAFT PUTTY (DBX) IS CAUSING THE CAGE TO MIGRATE. IT WAS CONCLUDED THAT: NEITHER THE MANUFACTURING DOCUMENTATION NOR THE INSPECTION RECORDS PRESENT ANY CONSPICUOUS FEATURES/TOPICS. EIT IS NOT AWARE OF ANY SIMILAR ISSUES/EVENTS. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE COMPLAINT DEVICE WAS NOT RETURNED AT JUAREZ LAB FOR EXAMINATION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE CIF EI H 5MM 4DEG L (P/N: CEI4050L, LOT: E20CL0433) WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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. DRAWING/SPECIFICATIONS REVIEWED: YES, NO ISSUES DEVICE HISTORY PART # CEI4050L LOT # E20CL0433 SUPPLIER: EIT ¿ BATCH1: LOT QTY OF 81 UNITS WERE RELEASED ON 09 SEPT 2020 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. 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. PART # CEI4050L. LOT # E20CL0433. SUPPLIER: EIT. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 09 SEPT 2020 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. 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. 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. 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 DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT 24 HOURS POST-OPERATIVE X-RAY TAKEN ON (B)(6), 2022 REVELED THAT THE TOP IMPLANT HAS MOVED SLIGHTLY AND SO WANTED TO REPORT IT AS A COMPLAINT. THE PATIENT IS FINE AND THERE ISN¿T A REVISION OPERATION PLANNED. DURING THE CASE, THEY TOOK SOME BONE GRAFT PUTTY (DBX) AND RUBBED THIS INTO THE CAGE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CIF EI H 5MM 4DEG L. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005579 CIF EI H 5MM 4DEG L INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP EIT EMERGING IMPLANT TECHNOLOGIES GMBH E20CL0433 04260397080078

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female UNK - BIOMATERIAL - PUTTY/PASTE: DBX: TRAUMA