BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA XP

    MDR report key: 12708428 · Received October 27, 2021

    Report

    Report Number
    3004893332-2021-00013
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 27, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    MAX
    PMA / PMN Number
    K150395
    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 THE PRODUCT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED. TO DATE, MULTIPLE COMMUNICATION ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE PRODUCT AND LOT NUMBER. IT WAS REPORTED, THAT THE SURGEON DETERMINED THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICES WERE DISCARDED DURING THE ADJACENT SEGMENT REVISION CASE. THEREFORE THE DEVICES WERE NOT RETURNED AND COULD NOT BE EVALUATED. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, THE LONGEVITY THE DEGREE OF POST LATERAL PSEUDARTHROSIS OR PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT (NO TRAUMA WAS REPORTED.). ROOT CAUSE OF THE IMPLANT BEING POSTERIOR FROM INTENDED PLACEMENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A PLIF PROCEDURE AT L4-L5, ORIGINAL SURGERY DATE UNKNOWN. REPORTEDLY, THE RADIOGRAPH NOTED THE RIGHT IMPLANT AT L4-L5 WAS NOW POSTERIOR FROM INTENDED PLACEMENT. PATIENT CONDITION AT THE TIME OF THE EVENT IS UNKNOWN. REVISION SURGERY IS PLANNED TO ADDRESS ADJACENT SEGMENT DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605289 OMEGA XP INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY MAX SPINAL ELEMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention