BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE, INCORPORATED

    MDR report key: 9556094 · Received January 6, 2020

    Report

    Report Number
    2031966-2020-00002
    Event Type
    Injury
    Date Received
    January 6, 2020
    Report Date
    January 6, 2020
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    ETN
    UDI-DI
    00887517118905
    PMA / PMN Number
    K112709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED FOR EVALUATION AS NO ALLEGED PRODUCT MALFUNCTION WAS MADE. NO RADIOGRAPHS OR PHOTOGRAPHS WERE PROVIDED THEREFORE ALLEGED EVENT COULD NOT BE CONFIRMED. REVIEW OF PROCEDURE NOTES PROVIDED OUTLINE THE URETERAL INJURY TOOK PLACE AS A RESULT OF POSSIBLE INTER-OPERATIVE DIFFICULTY. LABELING REVIEW: "...ACCESS: CARE SHOULD BE TAKEN TO AVOID EXPANDING THE BLADES TO THE MID-VERTEBRAL BODY OR BEYOND TO MINIMIZE PSOAS TRAUMA AND REDUCE THE RISK OF SEGMENTAL VESSEL INJURY..." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; PLEURAL EFFUSIONS, HEMOTHORAX, CHYLOTHORAX, PNEUMOTHORAX, SUBCUTANEOUS EMPHYSEMA, NEED FOR CHEST TUBE INSERTION, INTERCOSTAL NEURALGIA, RIB FRACTURE, DIAPHRAGM INJURY; ATELECTASIS; IMPOTENCE; AND PERMANENT PAIN AND/OR DEFORMITY..." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION, NONUNION OR DELAYED UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL, VASCULAR OR VISCERAL INJURY, METAL SENSITIVITY OR ALLERGIC REACTION TO A FOREIGN BODY, INFECTION..."

    Description of Event or Problem · 1

    ON UNKNOWN DATE, A PATIENT UNDERWENT THE FIRST OF A TWO-PART PROCEDURE AN EXTREME LATERAL INTERBODY FUSION AT L1/5 LEVELS VIA A RIGHT SIDED TRANSPSOAS RETROPERITONEAL APPROACH, WHERE THE URETERAL WAS REPORTED AS INJURED. SEVEN DAYS POST PROCEDURE THE SECOND HALF OF THE PROCEDURE, A POSTERIOR FIXATION FROM T12 TO ILIUM WAS COMPLETED WITH NO ADDITIONAL ISSUES REPORTED. DURING FOLLOW-UP, EIGHT DAYS POST-OPERATIVE, DISCHARGE WAS EFFLUXED FROM THE WOUND AND A COMPUTED TOMOGRAPHY REVEALED ABNORMAL ACCUMULATION FLUID AROUND THE RIGHT KIDNEY. 16 DAYS LATER, AN END TO END URETEROURETEROSTOMY WAS SUCCESSFULLY PERFORMED WITH NO POST-OP SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14688 NUVASIVE, INCORPORATED STIMULATOR, NERVE ETN NUVASIVE, INCORPORATED 1023501 00887517118905

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R