BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED PERCUTANEOUS ROD INSERTER

    MDR report key: 3131227 · Received May 23, 2013

    Report

    Report Number
    1649384-2013-00019
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ZIMMER SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K100845
    Removal / Correction Number
    1649384-06-05-2012-02-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED. THIS IS S THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADD'L ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATHFINDER NXT FIXED PERCUTANEOUS ROD INSERTER WAS DISCOVERED DURING INSPECTION TO HAVE A BROKEN TIP. THE INSTRUMENT WAS DISCOVERED WITHIN AN INSTRUMENT SET THAT IS NOT REGULARLY USED. IT IS UNK HOW AND WHEN THE PART WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229129 FIXED PERCUTANEOUS ROD INSERTER FIXED PERCUTANEOUS ROD INSERTER NKB ZIMMER SPINE INC. 3573-1 69FF

    Patients

    Seq Age Sex Outcome Treatment
    1