BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE BONE TRANSPORT SYSTEM

    MDR report key: 11613459 · Received April 5, 2021

    Report

    Report Number
    3006179046-2021-00218
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 2, 2021
    Report Date
    July 23, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00887517979469
    PMA / PMN Number
    K201567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE EVALUATION CAN BE PERFORMED AS IT IS IMPOSSIBLE TO TRACK THE DEVICE. BASED OFF THE INFORMATION THAT WAS RECEIVED BY THE PATIENT THE POTENTIAL ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO PATIENT ACTIVITY. THE INSTRUCTIONS FOR USE (IFU) STATES THAT PATIENTS SHOULD UTILIZE EXTERNAL SUPPORT AND/OR RESTRICT ACTIVITIES AS DIRECTED BY THE PHYSICIAN UNTIL CONSOLIDATION OCCURS. ALTHOUGH A DEVICE EVALUATION IS NOT POSSIBLE, A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER: 9021512 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

    NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 AFTER THE PATIENT FELL TWICE ON THE OPERATED SIDE, RESULTING IN THE NAIL BREAKING. IT WAS REPORTED THAT PRIOR TO THE FALL, THE NAIL HAD PERFORMED AS INTENDED AND THE PATIENT BONE HAD CONSOLIDATED. THERE WAS NO REPORT OF NAIL MALFUNCTION. THE BROKEN NAIL WAS REPLACED WITH A TRAUMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511131 PRECICE BONE TRANSPORT SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. BT115-10D380-7 9021512 00887517979469

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R