BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER SPINE SYSTEM

    MDR report key: 10490666 · Received September 3, 2020

    Report

    Report Number
    3004638600-2019-00013
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    October 9, 2019
    Report Date
    October 18, 2019
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MNH
    UDI-DI
    10840642106541
    PMA / PMN Number
    K152174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOVED PORTION OF THE DEVICE WAS RETURNED AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED DEVICE DISPLAYED VISUAL INDICATIONS OF USE IN A MANNER THAT EXCEEDED THE STRENGTH OF THE ASSEMBLY. A REVIEW OF THE DHR FOUND NO NONCONFORMANCES. BASED ON THE RESULTS OF THE EVALUATION A DEFINITIVE CONCLUSION CANNOT BE MADE.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO INSTALL A 10-LEVEL PEDICLE SCREW CONSTRUCT, THE SURGEON REPORTED A SINGLE SCREW SEPARATED DURING ATTEMPTED PLACEMENT INTO THE ILIUM. THE SCREW WAS PARTIALLY REMOVED AND THE CONSTRUCT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951091 SNIPER SPINE SYSTEM PEDICLE SCREW SYSTEM MNH SPINE WAVE, INC. 11-4741 942R22 10840642106541

    Patients

    Seq Age Sex Outcome Treatment
    1