BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPEDECTOMY PICK

    MDR report key: 6810898 · Received August 22, 2017

    Report

    Report Number
    1421101-2017-00002
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Report Date
    June 12, 2017
    Manufacturer
    AVALIGN GERMAN SPECIALTY INSTRUMENTS
    Product Code
    JYT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN TIP WAS NOT INCLUDED WITH THE BROKEN DEVICE FOR INVESTIGATION. THE MATERIAL AND HARDENING OF THE DEVICE IS LIKE INTENDED PER THE DHR REVIEW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEIR SALES REP REPORTED VIA EMAIL INSTRUMENT THAT BROKE DURING A CASE ON (B)(6) 2017. THE INSTRUMENT BROKE INSIDE A PATIENT AND THE BROKEN PIECE COULD NOT BE RETRIEVED DUE TO POTENTIAL RISK OF HEARING LOSS UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590099 STAPEDECTOMY PICK JYT AVALIGN GERMAN SPECIALTY INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1