BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS

    MDR report key: 19920140 · Received August 6, 2024

    Report

    Report Number
    3004893332-2024-00007
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    March 14, 2023
    Report Date
    August 7, 2024
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKG
    UDI-DI
    00840606106917
    PMA / PMN Number
    K151705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REVIEW OF DHR, THE RECORD STATES THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE AND MET ALL SPECIFIED PARAMETERS OF THE INSPECTION PROCESS WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC TO THIS PRODUCT ISSUE. THE DEVICE WAS NOT RETURNED AS THE PATIENT RETAINS THE DEVICE, AND COULD NOT BE EVALUATED. ADDITIONALLY, NO IMAGES OF THE DEVICE OR EVENT RADIOGRAPHS WERE PROVIDED FOR ANALYSIS. COMPLAINT CANNOT BE CONFIRMED. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, THE DEGREE OF PSEUDARTHROSIS (AS REPORTED), 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, BUT 3 YEARS OF CYCLICAL FATIGUE ON AN UNFUSED SEGMENT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. LABELING REVIEW NOTES: "POSSIBLE ADVERSE EVENTS... 2. DISASSEMBLY, BENDING, AND/OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS. 3. LOSS OF FIXATION...."

    Description of Event or Problem · 0

    RECEIVED REPORT FROM PATIENT. PATIENT STATES HE UNDERWENT 6 LEVEL POSTERIOR CERVICAL THORACIC FIXATION SURGERY AT C2-T1 ON (B)(6) 2019. PATIENT STATES HE WAS CLEARED FOR NORMAL ACTIVITY. REPORTEDLY T1 HAD NOT FUSED AND THE T1 SCREW FRACTURED 3 YEARS POST-OP. THE DEVICE WAS REMOVED/REVISED ON (B)(6) 2023. ON (B)(6) 2023 SURGEON ATTEMPTED A FUSION SURGERY AGAIN T1-T2. AND MOST RECENTLY THE CONSTRUCT WAS EXTENDED FOUR LEVELS FROM T2-T6. PATIENT STATES HE IS CURRENTLY DOING WELL BUT ENDURED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635756 LOTUS POSTERIOR CERVICAL SCREW SYSTEM NKG SPINAL ELEMENTS, INC 170030 00840606106917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention