BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MODULAR COUNTER TORQUE

    MDR report key: 3943582 · Received April 30, 2014

    Report

    Report Number
    2032593-2014-00020
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE TWO NEWPORT MODULAR COUNTER TORQUES 'WOULD NOT SLIDE OVER THE EXTENDED TAB SCREWS WITHOUT LITERALLY HAVING TO BE HAMMERED ON. BOTH SHAFTS WERE DIFFICULT TO PASS EXTENSIONS THROUGH. BUT ONE WAS WORSE THAN THE OTHER. THE SURGEON (LITERALLY) HAD TO HAMMER THEM ON.' ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT. THE CUSTOMER SAID HE WAS MOST CONCERNED THAT THE SURGEON HAD TO USE A GREAT DEAL OF FORCE WITH THE COUNTER TORQUE TO GO OVER THE TAB SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258756 NEWPORT MODULAR COUNTER TORQUE NEWPORT NKB SEASPINE, INC. AU4056202B

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWPORT DEPLOYER: 91-8431| NEWPORT MIS CAP/ROD COMBO 2: 60-0345