BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIEZOSURGERY

    MDR report key: 8164921 · Received December 14, 2018

    Report

    Report Number
    3005282635-2018-00002
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    April 1, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MECTRON S.P.A.
    Product Code
    JDX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A STRIP CRANIECTOMY FOR THE RELEASE OF THE SAGITTAL SUTURE, THE MEDICAL INSERT TIP BROKE WHILE IN USE. IT WAS REPORTED THAT THE PATIENT REQUIRED RE-OPENING OF THE INCISION AND ADDITIONAL ANESTHESIA TO REMOVE THE OBJECT. THE OBJECT WAS REMOVED WITHOUT ANY REPORTED COMPLICATION. NO FURTHER INFORMATION WAS RECEIVED REGARDING THE PATIENT STATUS. THE EVENT WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2018, BUT THE EXACT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005362 PIEZOSURGERY PIEZOSURGERY MEDICAL INSERT TIP JDX MECTRON S.P.A. MT1S-10 18000236

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention