BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE CUTTING

    MDR report key: 6986422 · Received October 30, 2017

    Report

    Report Number
    0002950261-2017-00018
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 30, 2017
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION IS ONGOING AND WE AWAIT RECEIPT OF THE PRODUCT FOR ANALYSIS. UPON COMPLETION OF THE INVESTIGATION, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS OPEN. THUS, THE ITEMS THAT SHOULD BE STERILE WERE NO LONGER STERILE UPON THE CUSTOMER RECEIVING THESE ITEMS THE EVENT OCCURRED PRIOR TO SURGERY AND UPON RECEIVAL INSPECTION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768280 OSCILLATING SAW BLADE CUTTING BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 256825

    Patients

    Seq Age Sex Outcome Treatment
    1