BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 11838684 · Received May 17, 2021

    Report

    Report Number
    3006179046-2021-00275
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Report Date
    July 23, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00887517951694
    PMA / PMN Number
    K180503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION OF THE RETURNED NAIL REVEALED THAT THE DISTRACTION ROD OF THE NAIL HAD DISCOLORATION, WHICH CONFIRMED DISCOLORATION FAILURE MODE. PER REPORTED FAILURE FUNCTIONAL TESTING WAS NOT APPLICABLE. THE DISCOLORATION FAILURE IS A PREVIOUSLY KNOWN ISSUE AND IS BEING INVESTIGATED UNDER A CAPA. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER: 9071106 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT. IN ADDITION, THE NAIL LISTED IN THIS COMPLAIN WAS BUILT PRIOR OF THE CAPA.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT AN EXPLANTED NAIL WAS NOTED TO HAVE CORROSION. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733477 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PS11.5-80SJ305 9071106 00887517951694

    Patients

    Seq Age Sex Outcome Treatment
    1