BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDENCE SPINAL CMT SYS, 11C

    MDR report key: 12745867 · Received November 3, 2021

    Report

    Report Number
    1526439-2021-02308
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 7, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NDN
    UDI-DI
    10705034209623
    PMA / PMN Number
    K060300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. H10 ADDITIONAL NARRATIVE: UPDATED DATA: H4, H6. DEVICE HISTORY LOT THE DHR OF PRODUCT CODE: 283910000. LOT : 306526. DHR WAS ELECTRONICALLY REVIEWED AND THE NON-CONFORMANCE NR 0009903/NR 0010049 HAS BEEN OBSERVED DURING THE MANUFACTURING PROCESS WITH NO LINK WITH COMPLAINT DESCRIPTION. THE PRODUCT WAS RELEASED ON: JULY 29, 2021 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT WAS SCHEDULED FOR PERCUTANEOUS VERTEBROPLASTY, DUE TO PATHOLOGICAL FRACTURE WITH LYTIC LESION OF THE LEFT HEMIBODY AND BLASTIA ON THE RIGHT SIDE. A CONFEDENSE VERTEBROPLASTY KIT IS USED, WHICH DUE TO A STONE CONSISTENCY OF THE PATIENT'S INJURY, WHEN REMOVING THE NEEDLE FROM THE PEDICLE WAS FRACTURED BY THE DISTAL BEVEL OF THE NEEDLE LEAVING THE SMALL PART IN THE PEDICLE. IT IS CHECKED WITH RESONANCE, AND ENSURED THAT IF IT REMAINS THERE AS IT IS SUCH A SMALL SEGMENT THERE IS NO WAY TO REMOVE IT. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CMT SYS, 11C. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645285 CONFIDENCE SPINAL CMT SYS, 11C CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SPINE INC 283910000 306526 10705034209623

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Required Intervention