BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE OCT NAVIGATED INSTRUMENTS

    MDR report key: 10623067 · Received October 2, 2020

    Report

    Report Number
    1833824-2020-00080
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 2, 2020
    Manufacturer
    PIONEER SURGICAL (D.B.A. RTI SURGICAL)
    Product Code
    OLO
    PMA / PMN Number
    K200095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECALLED UNDER 1833824-10/01/20-0002-R.

    Description of Event or Problem · 1

    A PIONEER SURGICAL TECHNOLOGY DISTRIBUTOR REPORTED THAT A STREAMLINE OCT NAVIGATED INSTRUMENT SET DID NOT INCLUDE A DRILL GUIDE. THIS WAS OBSERVED DURING A SET REVIEW AND NOT DURING A SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086993 STREAMLINE OCT NAVIGATED INSTRUMENTS NAVIGATIONAL INSTRUMENTATION OLO PIONEER SURGICAL (D.B.A. RTI SURGICAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other