BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 7006937 · Received November 7, 2017

    Report

    Report Number
    3006179046-2017-00060
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 10, 2017
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K141023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY THE PATIENTS PRECICE NAIL WOULD NOT DISTRACT. THE PHYSICIAN REVISED THE NAIL WITH A NEW PRECICE NAIL, WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786723 PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. P10.7-80E275 A160414-04

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R