BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM

    MDR report key: 20002013 · Received August 20, 2024

    Report

    Report Number
    3004638600-2024-00010
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 26, 2024
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    NKG
    UDI-DI
    10840642109719
    PMA / PMN Number
    K162639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, ONE SCREW ASSEMBLY BROKE DURING INTRAOPERATIVE SCREW POSITIONING. SCREW WAS REMOVED AND REPLACED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394660 PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM POSTERIOR CERVICO-THORACIC FIXATION SYSTEM NKG SPINE WAVE, INC. 662W164 10840642109719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown