BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 11886600 · Received May 26, 2021

    Report

    Report Number
    3006179046-2021-00281
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    July 19, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00887517950819
    PMA / PMN Number
    K180503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR TESTING. VISUAL INSPECTION REVEALED THAT THE ANTI-ROTATION LUG WAS DISENGAGED FROM THE HOUSING TUBE. THE BARBS OF THE ANTI-ROTATION LUG HAD MINOR DAMAGE FROM THE DISENGAGEMENT WHICH OCCURRED DURING THE REMOVAL OF THE DEVICE. AS THE NAIL WAS NOT FULLY ASSEMBLED, FUNCTIONAL TESTING AND X-RAY IMAGING WAS NOT APPLICABLE. THE ROOT CAUSE FOR THE DISENGAGEMENT OF THE ANTI-ROTATION LUG FROM THE HOUSING BODY CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER: 180417-15 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE NAIL CAME APART DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787663 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PS11.5-50B235 9012910 00887517950819

    Patients

    Seq Age Sex Outcome Treatment
    1