BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM

    MDR report key: 12863745 · Received November 23, 2021

    Report

    Report Number
    2031966-2021-00164
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 23, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MAX
    UDI-DI
    00887517733009
    PMA / PMN Number
    K203201
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION AS THEY WERE LEFT IN-SITU. NO RADIOGRAPHS WERE PROVIDED TO CONFIRM THE COMPLAINT. PATIENT'S POST-OPERATIVE PHYSICAL ACTIVITY AND BONE QUALITY ARE UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED THOUGH REVIEW OF THE REPORTED EVENT SUGGESTS POOR BONE QUALITY, EXCESSIVE POST-OPERATIVE PHYSICAL ACTIVITY OR MALPLACEMENT AS POSSIBLE CAUSE OR CONTRIBUTORS. NO ADDITIONAL INVESTIGATED CAN BE COMPLETED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: FRACTURE OF THE VERTEBRA." "WARNINGS, CAUTIONS AND PRECAUTIONS: THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. CARE SHOULD BE TAKEN TO ENSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT." "POST-OPERATIVE WARNINGS: DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION AS WELL AS TO OTHER COMPLICATIONS."

    Description of Event or Problem · 0

    ON (B)(6) 2021 A TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED AT L3/5. ON (B)(6) 2021 THE PATIENT REPORTED PAIN AND RADIOGRAPHS REVEALED A PEDICLE FRACTURE AT L5 AND SPONDYLOLISTHESIS OF L5/S CAUSED BY L5 PEDICLE FRACTURE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED AND SCREWS WERE ADDED TO S1 AND S2. NO ADDITIONAL INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757125 NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INCORPORATED 5181308P2 ML2035 00887517733009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female 5181308P2