BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFICIENT® POSTERIOR CERVICAL SPINE SYSTEM

    MDR report key: 19711511 · Received July 10, 2024

    Report

    Report Number
    3004638600-2024-00007
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    NKG
    UDI-DI
    10840642109764
    PMA / PMN Number
    K162639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CORRECTION TO PRIMARY UNIQUE DEVICE IDENTIFIER.

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, ONE SCREW BROKE DURING INSERTION. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172276 PROFICIENT® POSTERIOR CERVICAL SPINE SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG SPINE WAVE, INC. 663V144 10840642109764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown