BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 19838940 · Received July 26, 2024

    Report

    Report Number
    3006179046-2024-00148
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    August 12, 2020
    Report Date
    July 26, 2024
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
    Product Code
    HSB
    UDI-DI
    00887517951250
    PMA / PMN Number
    K180198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE (B)(6) (LIRC); NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. A ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. A REVIEW OF THE DHR DOCUMENTS INDICATES THE DEVICE WAS MANUFACTURED BY THE SPECIFIED REQUIREMENT AT THE TIME AND MET ALL THE REQUIRED INSPECTIONS UPON RELEASE TO FINISHED GOODS. ALL PRECISE STRYDE DEVICES HAVE BEEN RECALLED SINCE FEBRUARY 2021 AND ARE CURRENTLY OFF THE MARKET. THE COMPLAINTS INCLUDED REPORT OF PAIN AND BONY ABNORMALITIES AT THE INTERFACE BETWEEN THE TELESCOPING NAIL SEGMENTS. A CAPA WAS COMPLETED TO ADDRESS THE REPORTED EVENT OF CORROSION/BONY CHANGES (HYPERTROPHY, PERIOSTEAL REACTION AND OSTEOLYSIS). THE CAPA FOUND THE RISK MANAGEMENT (RM) PROCESS WAS INADEQUATE. FUTURE RM FILES FOR ALL ITERATIONS OF THE DEVICE WILL BE INTEGRATED FROM THE NUVASIVE SPECIALIZED ORTHOPEDICS-SPECIFIC RISK MANAGEMENT AND DESIGN CONTROL PROCESS/PROCEDURES INTO THE NUVASIVE, INC. GLOBAL RISK MANAGEMENT PROCESS/PROCEDURE.

    Description of Event or Problem · 0

    AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED, DETAILING THE EXAMINATION OF THE RETRIEVED IMPLANT. DURING THE ASSESSMENT, IT WAS NOTED THAT THE IMPLANT WAS UNABLE TO BE DISTRACTED AND RETRACTED AND FAILED THE FORCE TESTING. ADDITIONALLY, SURFACE DAMAGE GRADING REVEALED NOTABLE CORROSION, SCRATCHING, GALLING, SURFACE DEPOSITS AND DISCOLORATION. THE REPORT INDICATED THAT THE ROD WAS REMOVED AS PART OF A PLANNED PROCEDURE FOLLOWING THE ACHIEVEMENT OF THE DESIRED LENGTHENING. THE PATIENT HAD PREVIOUSLY REPORTED EXPERIENCING SIGNIFICANT THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705661 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PS11.5-80D265 9072506 00887517951250

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female