BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY

    MDR report key: 19043289 · Received April 4, 2024

    Report

    Report Number
    3004893332-2024-00003
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 4, 2024
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    PMA / PMN Number
    K191576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPH WAS RECEIVED DEPICTING A LEFT ILIAC TULIP SEPARATION FROM THE BONE SCREW SHANK, CONFIRMING THE EVENT. NO INDEX SURGERY INFORMATION OR PRODUCT INFORMATION PROVIDED. THE SUBJECT SCREW AND TULIP HEAD WERE NOT RETURNED FOR EVALUATION AS THEY REMAIN IN THE PATIENT. THE PATIENT IS ASYMPTOMATIC AND THERE IS NO REVISION PLANNED AT THIS TIME. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, THE DEGREE OF SPINAL INSTABILITY, THE DEGREE OF PSEUDARTHROSIS, PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT (NO TRAUMA WAS REPORTED.) THESE FACTORS DICTATE THE LONGEVITY OF THE IMPLANT. ROOT CAUSE OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT POSTERIOR LUMBAR SPINAL FUSION SURGERY FROM L2- PELVIS. INITIAL SURGERY DATE WAS NOT PROVIDED. DURING ROUTINE FOLLOW UP, IT WAS NOTED THAT THE TULIP HEAD SEPARATED FROM THE LEFT ILIAC BONE SCREW. PATIENT IS ASYMPTOMATIC AND THERE IS NO PLAN FOR REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86533 MERCURY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown