BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 11886455 · Received May 26, 2021

    Report

    Report Number
    3006179046-2021-00280
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 29, 2021
    Report Date
    July 23, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00887517950932
    PMA / PMN Number
    K180503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE RETURNED PRECICE STRYDE DEVICE WAS OBSERVED AND THE ANTI-ROTATION LUG WAS DISENGAGED FROM THE HOUSING TUBE WHICH CONFIRMED THE REPORTED FAILURE MODE. THE BARBS OF THE ANTI-ROTATION LUG HAD MINOR DAMAGE, LIKELY FROM THE DISENGAGEMENT WHICH OCCURRED DURING THE REMOVAL OF THE DEVICE. FUNCTIONAL TESTING AND X-RAY DID NOT APPLY DUE TO THE NAIL CONDITION (IT WAS NOT FULLY ASSEMBLED). IN ADDITION, ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT DURING IMPLANT REMOVAL AND SENT TO NSO FOR INVESTIGATION. DEVICE HISTORY REVIEW: THE WORK ORDER WAS REVIEWED AND CONFIRMED THE DEVICE PASSED ALL INSPECTIONS PER THE ACCEPTANCE TESTS AT0070 REV-B AND AT0068 REV-C. THE MANUFACTURING X-RAY IMAGE SHOWED THE ANTI-ROTATION LUG (CROWN) WAS SEATED PROPERLY IN THE HOUSING BODY. IN ADDITION, THE DEVICE WAS PROPERLY MANUFACTURED AND INSPECTED PER THE WORK ORDER FOR LOT#: 9060507.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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 DURING EXPLANT THE NAIL CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787633 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PS13.0-80B335 9060507 00887517950932

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR