BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK EX-5 STR

    MDR report key: 4476322 · Received January 29, 2015

    Report

    Report Number
    9611253-2015-00008
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Manufacturer
    NAKANISHI INC (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K962540
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (EX-5 STR, LOT NO.1107). NAKANISHI INC. CONDUCTED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. THE INFORMATION IS SUPPLIED BY STRYKER INSTRUMENTS-(B)(4) (IMPORTER).

    Description of Event or Problem · 1

    REF IMP: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69878 NSK EX-5 STR HANDPIECE, CONTRA AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC (NSK)

    Patients

    Seq Age Sex Outcome Treatment
    1