BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 7216395 · Received January 24, 2018

    Report

    Report Number
    1526439-2018-50068
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Report Date
    January 10, 2018
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    UDI-DI
    10705034209630
    PMA / PMN Number
    K060300
    Removal / Correction Number
    1526439-12-15-2017-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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

    JJM STAFF ADVISED THAT ONE OF OUR CUSTOMER (B)(6) HOSPITAL (B)(6), HAS USED A BOX OF AFFECTED CONFIDENCE STOCK IN A CASE. HOSPITAL RECEIVED RECALL LETTER FROM RECALL SERVICE. THE STOCK WAS NOT CONSIGNED AS THE RADIOLOGY DEPARTMENT AT PRINCE CHARLES PURCHASE STOCK AND UNFORTUNATELY HAD PURCHASED 2 OF THE AFFECTED ITEMS. UNKNOWN_SPD: 1 X CONFIDENCE CEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60754 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE 154957 10705034209630

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR