BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIF EI H 8MM 4DEG L

    MDR report key: 10200034 · Received June 26, 2020

    Report

    Report Number
    3013730328-2020-00021
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Report Date
    April 27, 2020
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: DEVICE HISTORY LOT PART # CIF EI H 8MM 4DEG L. LOT # E19LA0084. SUPPLIER LOT # E19LA0084. EXPIRATION DATE: 30-JUN-2024. RELEASE TO WAREHOUSE DATE: 20-JUN-2019. SUPPLIER: EIT. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. H3, H4, H6 INVESTIGATION SUMMARY: THE DEVICE AND PACKAGING WERE NOT RETURNED. A PHOTO INVESTIGATION WAS PERFORMED, REFERENCE PC ATTACHMENTS. INVESTIGATION SUMMARY: PER DRAWING, THE CORRECT NOMINAL DIMENSION IS 14MM. REVIEW OF THE IMAGE IN ATTACHMENT DEPICTING THE DEVICE'S LABEL, AND THE DEVICE'S SURGICAL TECHNIQUE IN ATTACHMENT "CONDUIT - STG CERVICAL (ENGLISH) CONFIRMED THE REPORTED DISCREPANCY BETWEEN THE LABEL AND SURGICAL TECHNIQUE FOR THE DEVICE'S ANTERIOR-POSTERIOR DEPTH : 14MM VS. 13MM, RESPECTIVELY. THE CURRENT OUS SURGICAL TECHNIQUE WAS REVIEWED, CONFIRMING THE REPORTED DIMENSIONAL DISCREPANCY FOR THE CURRENT OUS SURGICAL TECHNIQUE AS WELL. THE OUS SURGICAL TECHNIQUE'S ARE THEREFORE INCORRECT; THERE WERE NO ISSUES IDENTIFIED WITH THE DEVICE'S LABEL. THE CURRENT US SURGICAL TECHNIQUE WAS REVIEWED AS WELL. THE US SURGICAL TECHNIQUE HAS THE CORRECT DIMENSION OF 14MM NOTED; THEREFORE, NO ISSUES WERE OBSERVED WITH THE US SURGICAL TECHNIQUE. INVESTIGATION CONCLUSION: THE REPORTED CONDITION WAS CONFIRMED DURING INVESTIGATION. THE ISSUE WAS ESCALATED TO (B)(4) AND WILL BE INVESTIGATED FURTHER WITHIN THE PIE-FIELD ACTION PROCESS; REFERENCE QUALITY SYSTEM RECORD (B)(4) FOR ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    UDI IS UNAVAILABLE AS THIS IS AN EU ONLY PRODUCT. REPORTER IS COMPANY REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION SUMMARY: 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 HISTORY: PART # CIF EI H 8MM 4DEG L, LOT # E19LA0084, SUPPLIER LOT # E19LA0084, EXPIRATION DATE: UNK, RELEASE TO WAREHOUSE DATE: 20-JUN-2019, SUPPLIER: EIT. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DURING MEDICAL TRAINING FOR CONDUIT CIF IN THE SURGICAL TECHNIQUE ON SHOWPAD, THE DIMENSIONS FOR THE LARGE FOOTPRINT ARE INCORRECTLY DESCRIBED ON PAGE 4. THE FOOTPRINT LARGE IS DESCRIBED AS 18X13 MM WHERE AS ON THE LABEL OF THE PRODUCT IT IS 18X14 MM. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667335 CIF EI H 8MM 4DEG L INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP EIT EMERGING IMPLANT TECHNOLOGIES GMBH E19LA0084

    Patients

    Seq Age Sex Outcome Treatment
    1