BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 16147347 · Received January 12, 2023

    Report

    Report Number
    1526439-2023-00061
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 1, 2022
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NDN
    UDI-DI
    10705034209630
    PMA / PMN Number
    K060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: H4 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 283913000 LOT NUMBER: 359235 IT WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 31/10/2022 QTY: 48 CEMENT NUMBER: PRODUCT CODE : 183901001 / BATCH NUMBER : 3896550 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J EMPLOYEE. INITIAL REPORTER: (B)(6). 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. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED THAT THERE WAS DAMAGED WATER SUPPLY MECHANISM. WATER LEAKS OUT FROM UNDER THE CORK DURING APPLICATION. NO CONSEQUENCES FOR THE PATIENT, NO PROLONGATION OF THE PROCEDURE. THIS REPORT IS FOR ONE (1) CONFIDENCE KIT, NO NEEDLES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439185 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY CLOSE NDN DEPUY SPINE INC 283913000 359235 10705034209630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown