BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALVO SPINE SYSTEM

    MDR report key: 10906766 · Received November 25, 2020

    Report

    Report Number
    3004638600-2020-00005
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    NKB
    UDI-DI
    10840642132984
    PMA / PMN Number
    K182954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE POST-OPERATIVE FOLLOW UP, FOUR WEEKS POST-OPERATIVELY, THE SURGEON IDENTIFIED A SEPARATED SCREW IN THE PEDICLE SCREW CONSTRUCT VIA RADIOGRAPH. THE PEDICLE SCREW AND CONSTRUCT WERE LEFT IN PLACE AS THE SURGEON REPORTED THE PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372102 SALVO SPINE SYSTEM PEDICLE SCREW SYSTEM NKB SPINE WAVE, INC. 11-6530 UNK 10840642132984

    Patients

    Seq Age Sex Outcome Treatment
    1