BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFIDENCE KIT (7CC)

    MDR report key: 8428505 · Received March 18, 2019

    Report

    Report Number
    1526439-2019-51470
    Event Type
    Death
    Date Received
    March 18, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 22, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NDN
    UDI-DI
    10705034209616
    PMA / PMN Number
    K060300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)((4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR KIT AND CEMENT WERE CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. WITHOUT THE PRODUCT, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. A REVIEW OF THE LOT HISTORY FOR THIS KIT AND ITS ASSOCIATED CEMENT DID NOT FIND ANY ISSUES PERTINENT TO THIS EVENT. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLE BE PROVIDED AT A LATER TIME, THIS COMPLAINT WILL BE REOPENED AND DEVICE EVALUATED. 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

    PRODUCT COMPLAINT # (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    (B)(4). IT WAS REPORTED, THE SURGEON NOTICED ALTERATIONS TO THE CARDIAC FREQUENCY OF THE PATIENT'S SUBSEQUENTLY TO THE USE OF CONFIDENCE CEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221550 CONFIDENCE KIT (7CC) CONFIDENCE CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SPINE INC 201208 10705034209616

    Patients

    Seq Age Sex Outcome Treatment
    1 Death