BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY

    MDR report key: 8192264 · Received December 21, 2018

    Report

    Report Number
    3004893332-2018-00007
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    PMA / PMN Number
    K083230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW CANNOT BE COMPLETED AT THIS TIME AS NOT PRODUCT INFORMATION HAS BEEN PROVIDED. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. RECEIVED RADIOGRAPHS DEPICTING TWO BONE SCREWS FRACTURED MID SHAFT AT S1. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, OR PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS. DURATION OF IMPLANTATION (RELATED TO DEVICE FATIGUE) OR PROGRESSION TOWARDS BONY FUSION IS UNKNOWN. ROOT CAUSE OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED. LABELING REVIEW NOTES: "POSSIBLE ADVERSE EVENTS ... DISASSEMBLY, BENDING, AND/OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS. LOSS OF FIXATION....".

    Description of Event or Problem · 1

    PATIENT RECEIVED A POSTERIOR LATERAL SPINAL FUSION SURGERY AT L4-S1 WITH BILATERAL FIXATION. NO INTERBODIES APPEAR TO BE USED. INITIAL SURGERY DATE UNKNOWN. ON (B)(6) 2018 RADIOGRAPH DEPICTED BOTH BONE SCREWS AT S1 TO BE FRACTURED. REVISION SURGERY IS PLANNED TO REPLACE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028787 MERCURY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention