BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK EX-5 STR

    MDR report key: 4476325 · Received January 29, 2015

    Report

    Report Number
    9611253-2015-00007
    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 INVESTIGATION APPROACH NAKANISHI INC, (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (EX-5 STR, LOT NO. 1007). 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
    69879 NSK EX-5 STR HANDPIECE, CONTRA AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC (NSK)

    Patients

    Seq Age Sex Outcome Treatment
    1