BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM

    MDR report key: 19992554 · Received August 15, 2024

    Report

    Report Number
    3004638600-2024-00009
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    NKG
    UDI-DI
    10840642109702
    PMA / PMN Number
    K162639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ATTEMPTS TO OBTAIN ADDITIONAL DETAILS HAVE BEEN UNSUCCESSFUL. BASED ON THE INFORMATION AVAILABLE, THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, ONE SCREW BROKE DURING INSERTION. NO PATIENT CONSEQUENCE WAS REPORTED. SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177830 PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM POSTERIOR CERVICO-THORACIC FIXATION SYSTEM NKG SPINE WAVE, INC. UNK 10840642109702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown