BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST IBF HI H 12MM 8DEG 26X9

    MDR report key: 19729205 · Received July 12, 2024

    Report

    Report Number
    3013730328-2024-00056
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 13, 2024
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    OVD
    UDI-DI
    04260557823934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. H11 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H4, H6: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE PACKAGE LABELED FOR TLIF-C HI 11MM 8DEG 32X12 (ARTICLE: THI81132) ACTUALLY CONTAINED A PLIF H 12MM 8DEG 26/9 (ARTICLE: PHI81206). THIS CONFIRMS THE EVENT DESCRIPTION OF RECEIVING A WRONG CONTENT/ITEM INSIDE A DIFFERENT PACKAGE. THE REPORTED ALLEGATION CAN BE CONFIRMED THROUGH THE PHOTO INVESTIGATION AS THE OBSERVED CONDITION (WRONG ITEM INSIDE THE PACKAGE) MATCHES THE COMPLAINED ISSUE. 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. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF POST IBF HI H 12MM 8DEG 26X9 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MANUFACTURING. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE COMPLAINT ISSUE. DEVICE HISTORY REVIEW (DHR): PART # PHI81206, LOT # E22LA0427, SUPPLIER: (B)(4). BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON MAR 31, 2023 WITH NO DISCREPANCIES. THE FOLLOWINGS NRS ARE GENERATED FOR LOT E22LA0427. 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. THE INITIAL COMPLAINT WAS REVIEWED, AND IT WAS DETERMINED THAT THE POST IBF HI H 12MM 8DEG 26X9 IS NOT REPORTABLE. THE POST IBF HI H 12MM 8DEG 26X9 WAS NOT ALLEGED TO HAVE ANY DEFECT. THE PACKAGING ISSUE REPORTED IN THIS EVENT IS CAPTURED IN MANUFACTURER REPORT NUMBER 3013730328-2024-00055. 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

    IT WAS REPORTED THAT ON (B)(6) 2024, THE WRONG CONTENT WAS INSIDE THE PACKAGE. THE POST IBF HI H 12MM 8DEG 26X9 WAS IN THE WRONG PACKAGE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER IMPLANT WITH THE SAME ARTICLE NUMBER. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE POST IBF HI H 12MM 8DEG 26X9. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 0

    THE INITIAL COMPLAINT WAS REVIEWED, AND IT WAS DETERMINED THAT THE POST IBF HI H 12MM 8DEG 26X9 IS NOT REPORTABLE. THE POST IBF HI H 12MM 8DEG 26X9 WAS NOT ALLEGED TO HAVE ANY DEFECT. THE PACKAGING ISSUE REPORTED IN THIS EVENT IS CAPTURED IN MANUFACTURER REPORT NUMBER 3013730328-2024-00055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347014 POST IBF HI H 12MM 8DEG 26X9 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD EIT EMERGING IMPLANT TECHNOLOGIES GMBH E22LA0427 04260557823934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown