BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 11682355 · Received April 16, 2021

    Report

    Report Number
    3006179046-2021-00242
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 16, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K180503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION AND THE DEVICE LOT NUMBER WAS NOT PROVIDED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. IF ANY RELEVANT ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: ROLFING, JAN DUEDAL, ET AL (2021). PAIN, OSTEOLYSIS, AND PERIOSTEAL REACTION ARE ASSOCIATED WITH THE STRYDE LIMB LENGTHENING NAIL: A NATIONWIDE CROSS-SECTIONAL STUDY. ACTA ORTHOPAEDICA, VOLUME 92. WEB ADDRESS TO ARTICLE: HTTPS://DOI.ORG/10.1080/17453674.2021.1903278.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA REVIEW OF LITERATURE THAT A PATIENT EXPERIENCED PAIN, OSTEOLYSIS, AND HYPERTROPHY. THERE WAS NO REPORT OF DEVICE REVISION OR REMOVAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577150 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other