BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 10787065 · Received November 4, 2020

    Report

    Report Number
    2031966-2020-00200
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 29, 2020
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MPQ
    PMA / PMN Number
    K142205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. NO FILMS/XRAYS CONFIRMING THE ISSUE COULD BE PROVIDED. THE SPINE SURGEON STATED THERE WAS NO DEFECT OR PROBLEM WITH NUVASIVE PRODUCTS THAT LED TO THE DIAPHRAGMATIC HERNIA. THE ROOT CAUSE WOULD BE CONSIDERED THE RESULT OF INADVERTENT INSTRUMENT OR IMPLANT CONTACT WITH THE PATIENTS DIAPHRAGM AND A UNINTENDED USE ERROR. "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; DYSPHAGIA; DYSPHONIA; DURAL TEAR OR CSF LEAK; ESOPHAGEAL INJURY; WORSENED NEUROLOGIC STATUS; VERTEBRAL ARTERY INJURY; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; IMPOTENCE; AND PERMANENT PAIN AND/OR DEFORMITY..."

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT XLIF PROCEDURE WITH X-CORE ON (B)(6) 2020. THE SPINE SURGEON RESECTED THE PATIENT¿S TH11 RIB IN ORDER TO APPROACH TO L1 AND IMPLANTED X-CORE. HOWEVER POST-OPERATIVELY, THE PATIENT HAD DIFFICULTY BREATHING, SO ANOTHER SURGEON EXAMINED THE PATIENT AND FOUND A DIAPHRAGMATIC HERNIA. AS A RESULT OF THE EXAMINATION, IT FOUND THAT THE PATIENT¿S STOMACH HAD ENTERED THE PLEURAL SIDE THROUGH THE DIAPHRAGMATIC HOLE AND HAD COMPRESSED THE PATIENT¿S LUNGS. ON (B)(6) 2020, THE SURGEON SUTURED THE DIAPHRAGMATIC HOLE. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. THE SPINE SURGEON CONSIDERS THAT THERE WAS NO DEFECT WITH OUR PRODUCTS. NO FILMS/XRAYS CONFIRMING THE ISSUE COULD BE PROVIDED. THE PATIENT IS RECOVERING WELL FROM THE DIAPHRAGMATIC HERNIA.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. THE SPINE SURGEON STATED THERE WAS NO DEFECT WITH THE MATERIALS THAT LED TO THE DIAPHRAGMATIC HERNIA. NO FILMS/XRAYS CONFIRMING THE ISSUE COULD BE PROVIDED. "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; DYSPHAGIA; DYSPHONIA; DURAL TEAR OR CSF LEAK; ESOPHAGEAL INJURY; WORSENED NEUROLOGIC STATUS; VERTEBRAL ARTERY INJURY; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; IMPOTENCE; AND PERMANENT PAIN AND/OR DEFORMITY..." DEVICE REMAINS IN-SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2020 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION CORPECTOMY PROCEDURE. AS PER REPORTER, THE SPINE SURGEON RESECTED THE PATIENT¿S TH11 RIB IN APPROACH TO L1 AND IMPLANTED THE VERTEBRAL BODY REPLACEMENT. POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING DIFFICULTY BREATHING, ANOTHER SURGEON EXAMINED THE PATIENT AND FOUND A DIAPHRAGMATIC HERNIA. ON (B)(6) 2020, THE DIAPHRAGMATIC HOLE WAS SUTURED. PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248538 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM MPQ NUVASIVE, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R