BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM

    MDR report key: 17500369 · Received August 10, 2023

    Report

    Report Number
    3004638600-2023-00010
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Report Date
    July 11, 2023
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    NKG
    UDI-DI
    10840642111217
    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

    THE DEVICE WAS NOT REMOVED AND THEREFORE NOT 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

    AT APPROXIMATELY 8 WEEKS POST-OPERATIVELY, A LOOSE LOCKING SCREW AND SPINAL ROD IN A PEDICLE SCREW CONSTRUCT WERE IDENTIFIED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280391 PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM POSTERIOR CERVICO-THORACIC FIXATION SYSTEM NKG SPINE WAVE, INC. UNK 10840642111217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown