BEUDAMED
    FDA Adverse Event Other Summary report: N

    PMT TORQUE DRIVER

    MDR report key: 3001993 · Received March 8, 2013

    Report

    Report Number
    2182979-2013-00002
    Event Type
    Other
    Date Received
    March 8, 2013
    Date of Event
    June 20, 2009
    Report Date
    March 4, 2013
    Manufacturer
    PMT CORP.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PMT CORPORATION WAS NOTIFIED OF THIS MAUDE THROUGH CURRENT LITIGATION. THE TORQUE DRIVER WAS NOT RETURNED TO PMT FOR INSPECTION/INVESTIGATION. NO OTHER PRODUCTS USED ON THE PATIENT WERE RETURNED TO PMT FOR INSPECTION/INVESTIGATION. THE USER DOES NOT HAVE INFORMATION ON THE SPECIFIC TORQUE DRIVER USED ON THIS PATIENT.

    Description of Event or Problem · 1

    A MAUDE REPORT WAS PROVIDED TO PMT CORPORATION. THE EVENT WAS REPORTED ON THE MAUDE REPORT AS FOLLOWS: A MALE PATIENT WAS FITTED WITH A PMT HALO SYSTEM IN (B)(6) 2009. A PMT TORQUE DRIVER WAS USED TO TIGHTEN THE SKULL PINS. BASED ON INFORMATION RECEIVED, ONE OF THE SKULL PINS WAS DRIVEN TOO FAR THROUGH THE SKULL AND INTERVENTION HAD TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99429 PMT TORQUE DRIVER TORQUE DRIVER HXX PMT CORP. 1201-8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention