BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE SPINAL CMT SYS, 11C

    MDR report key: 22952257 · Received September 3, 2025

    Report

    Report Number
    1526439-2025-01111
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 11, 2025
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NDN
    UDI-DI
    10705034209623
    PMA / PMN Number
    K060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: 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. H11 ADDITIONAL NARRATIVE: ADDED: B5. 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. H11 ADDITIONAL NARRATIVE: H3, H6: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY REVIEW: A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 283910000. LOT NUMBER: 416677. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 26-NOV-2024. MANUFACTURING SITE: JABIL LE LOCLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE HYDRAULIC PUMP WOULD SPRAY OUT THE HYDRAULIC FLUID AND NOT DEPLOY THE CEMENT. THE CEMENT WAS MIXED FOR ONE MINUTE, ATTACHED TO THE HYRAUDLIC PUMP, AND HANDED UP TO THE FIELD FOR USE. THE PUMP WAS NOT ABLE TO BE CONNECTED IN A WAY THAT WOULD CAUSE THE CEMENT TO FLOW AND THE FLUID KEPT LEAKING. THERE WAS A SURGICAL DELAY OF 2 MINUTES. A NEW CEMENT PUMP OPENED AND ATTACHED TO MIXED CEMENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO GENERATION OF FRAGMENTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: A; WAS THERE ANY ALLEGATION AGAINST THE CEMENT? NONE. B. HOW WAS THE CEMENT PREPARED FOR USE? PER TECH GUIDE. C. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? THE MIXING WELL FROM THE KIT. D. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? THE CEMENT WAS MIXED FOR ONE MINUTE, ATTACHED TO THE HYRAUDLIC PUMP, AND HANDED UP TO THE FIELD FOR USE. E. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? AN OPEN CANNULA THROUGH A VERSE ALIGNMENT GUIDE AND SCREW. F. CAN YOU PROVIDE THE QUANTITY USED OF THE CEMENT PRODUCT? 10CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336041 CONFIDENCE SPINAL CMT SYS, 11C CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SPINE INC 416677 10705034209623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown