BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN DRILLABLE INJECT 5CC-STERILE

    MDR report key: 4533729 · Received February 22, 2015

    Report

    Report Number
    1719045-2015-10120
    Event Type
    Malfunction
    Date Received
    February 22, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    PK073303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EXPIRATION DATE: REPORTED AS 10/2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    IT WAS REPORTED THAT A NORIAN DRILLABLE WAS ACCIDENTALLY USED WITH AND EXPIRED DAE. THERE WERE NO REPORTS OF ANY PATIENT HARM OR SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124873 NORIAN DRILLABLE INJECT 5CC-STERILE FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV SYNTHES MONUMENT N004747

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR