BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCENT XP

    MDR report key: 11935980 · Received June 3, 2021

    Report

    Report Number
    3004893332-2021-00006
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 3, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    MAX
    UDI-DI
    00840606114882
    PMA / PMN Number
    K182584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOGRAPHS WERE NOT RECEIVED TO DETERMINE THE INITIAL PLACEMENT OR THE DEGREE OF MIGRATION AT THE TIME OF THE EVENT. COMPLAINT CANNOT BE CONFIRMED. RETURNED DEVICE WAS DISASSEMBLED AND SCRATCHED AS A RESULT OF THE REMOVAL. THE DEVICE MEETS SPECIFICATIONS EXCEPT FOR THE MISSING REAR SCREW THAT WAS NOT RETURNED (LOST) AS A RESULT OF THE REMOVAL. A MECHANICAL MALFUNCTION OR COLLAPSE IS NOT APPARENT IN THE SUBJECT DEVICE. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POSTOPERATIVE CARE INSTRUCTIONS, OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT. THE ROOT CAUSE OF THE MIGRATION IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2020 PATIENT RECEIVED AN INTERBODY DEVICE AT L5-S1. PATIENT WAS ASYMPTOMATIC FOR APPROXIMATELY 7 MONTHS POST-OPERATIVELY, WHEN DISPLAYED LOCALIZED PAIN IN HIP AND BUTTOCK AREA. REPORTEDLY UPON EVALUATION, THE DEVICE HAD MIGRATED POSTERIORLY. RADIOGRAPHS WERE NOT RECEIVED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824545 LUCENT XP INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY MAX SPINAL ELEMENTS, INC P11351-508 193001 00840606114882

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention