BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE, T NON-RATCHETING TLR 90 IN-LBS

    MDR report key: 6973037 · Received October 24, 2017

    Report

    Report Number
    3012447612-2017-00569
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    February 21, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK132884
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE VENDOR FOR RECALIBRATION WITHOUT BEING EVALUATED. THEREFORE, NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT DETECT ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TORQUE OUTPUT OF A TORQUE LIMITING HANDLE WAS FOUND OUTSIDE OF THE ADEQUATE PERFORMANCE RANGE. THIS WAS DETECTED DURING A PRELIMINARY CALIBRATION CHECK BY ZIMMER BIOMET SPINE PERSONNEL. THERE ARE NO SPECIFIC SURGICAL PROCEDURES ASSOCIATED WITH THIS HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751501 MODULAR HANDLE, T NON-RATCHETING TLR 90 IN-LBS PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 77BQ-066

    Patients

    Seq Age Sex Outcome Treatment
    1