BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10926205 · Received December 1, 2020

    Report

    Report Number
    1030489-2020-01718
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    February 11, 2019
    Report Date
    December 1, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS UNKNOWN. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A LITERATURE STATING: A CASE OF MULTILEVEL PERCUTANEOUS VERTEBROPLASTY FOR VERTEBRAL METASTASES RESULTING IN TEMPORARY PARAPARESIS. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH. 2019. 48(2) 1¿5. SUMMARY: PERCUTANEOUS VERTEBROPLASTY (PVP) IS A MINIMALLY INVASIVE TREATMENT THAT HAS BEEN WIDELY USED FOR THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AND VERTEBRAL TUMORS. HOWEVER, THE MAXIMUM NUMBER OF VERTEBRAL SEGMENTS TREATED IN A SINGLE PVP REMAINS CONTROVERSIAL. FURTHERMORE, PVP MAY CAUSE COMPLICATIONS, INCLUDING CEMENT LEAKAGE, PULMONARY EMBOLISM, BONE CEMENT TOXICITY, AND SPINAL NERVE-PUNCTURE INJURY. PATIENT DIAGNOSED WITH LATE-STAGE LUNG CANCER UNDERWENT PERCUTANEOUS VERTEBROPLASTY WITH NO BONE CEMENT LEAKAGE OR SPINAL CORD INJURY, BUT DEVELOPED TEMPORARY PARAPARESIS WITH RESOLUTION. VERTEBRAL PEDICLES OF T7¿T10 WERE PUNCTURED USING MEDTRONIC KYPHON VR SPECIALIZED INSTRUMENTS. REPORTED EVENTS: 1. THE VERTEBRAL PEDICLES OF T7¿T10 WERE PUNCTURED USING SPECIALIZED INSTRUMENTS (KYPHONVR, INC., MEDTRONIC, MINNEAPOLIS, MN, USA). 2. A T10 BONE TISSUE BIOPSY WAS PERFORMED AND THE RESULT CONFIRMED VERTEBRAL METASTASES FROM LUNG CANCER. 3. VITALS WERE NORMAL. NO SYMPTOMS INDICATING NEUROLOGICAL DAMAGE WERE OBSERVED THROUGHOUT THE OPERATION. 4. HOWEVER, WHEN THE PATIENT TURNED FROM A PRONE TO A SUPINE POSITION, SHE EXPERIENCED MOVEMENT AND SENSORY DISTURBANCES TO BOTH LOWER EXTREMITIES, WHICH BECAME PROGRESSIVELY WORSE. AFTER 15 MINUTES, THE PATIENT PRESENTED WITH COMPLETE ABSENCE OF SENSATION AND MUSCLE STRENGTH BELOW THE COSTAL ARCH AND IN BOTH LOWER EXTREMITIES, DECREASED MUSCLE TONE, UNSUCCESSFUL ELICITATION OF TENDON REFLEX, AND RELAXATION OF THE ANAL SPHINCTER. VITALS WERE NORMAL AND MEDICATION WAS ADMINISTERED IN CASE OF SPINAL CONCUSSION. 5. THE MUSCLE STRENGTH IN HER LOWER LIMBS GRADUALLY INCREASED 2 HOURS LATER AND THE SENSE OF PAIN AND TENDERNESS BELOW THE COSTAL ARCH AND IN HER LOWER LIMBS BEGAN TO RECOVER. HER MOVEMENT AND SENSATION HAD RETURNED TO NORMAL AFTER 4 HOURS AND THE PATIENT WAS ABLE TO WALK UNAIDED AND WITHOUT DISCOMFORT ON THE FIRST DAY AFTER SURGERY. 6. SHE WAS DISCHARGED ON THE FOURTH POSTOPERATIVE DAY AND ADMITTED TO THE DEPARTMENT OF RADIOTHERAPY FOR FURTHER TREATMENT. 7. FOLLOW-UP AT 3 MONTHS SHOWED NORMAL SENSORY AND MOTOR FUNCTIONS OF BOTH LOWER LIMBS. THE VISUAL ANALOG SCALE SCORE FOR THE THORACIC AND LUMBAR SURGICAL REGION IMPROVED FROM EIGHT PREOPERATIVELY TO TWO POSTOPERATIVELY. 8. THE RESULTS OF THE CURRENT PATIENT¿S PREOPERATIVE PHYSICAL EXAMINATION AND HER RECOVERY PROCESS SUGGESTED THAT HER TEMPORARY PARA PARESIS MAY HAVE BEEN CAUSED BY THE LOCAL ANESTHETIC DRUGS. THESE DRUGS MAY HAVE SLOWLY INFILTRATED INTO THE SPINAL CANAL, AND FINALLY BLOCKED THE SPINAL CORD AFTER OPERATION, RESULTING IN PROGRESSIVE DECLINE OF SENSATION AND MUSCLE STRENGTH IN THE BILATERAL LOWER EXTREMITIES. HOWEVER, THE EFFECT OF THE LOCAL ANESTHETICS GRADUALLY ATTENUATED, AND THE PATIENT RECOVERED TO HER PRE OPERATIVE STATE. NOTABLY, THE PATIENT GRADUALLY RECOVERED MOVEMENT FOLLOWED BY SENSATION, SIMILAR TO THE CHARACTERISTICS OF RECOVERY FOLLOWING SPINAL NERVE BLOCKAGE AFTER SPINAL ANESTHESIA. THERE WERE FOUR POSSIBLE CAUSES OF THE PATIENT¿S PARAPARESIS: SPINAL CORD INJURY, BONE CEMENT LEAKAGE, CEMENT SYNDROME, AND HYSTERICAL PARALYSIS. POSTOPERATIVE CT AND X-RAY IMAGES SHOW MOST PMMA LOCATED IN THE VERTEBRAL BODIES, WITH VERY SLIGHT LEAKAGE OUTSIDE T8, BUT NOT INTO THE SPINAL CANAL. THE PATIENT'S MEDICAL HISTORY INCLUDES LATE-STAGE LUNG CANCER 8 MONTHS PREVIOUSLY, TWO CYCLES OF CHEMOTHERAPY PRIOR TO HOSPITAL ADMISSION PERSISTENT AND SEVERE THORACOLUMBAR BACK PAIN AND WAS DIAGNOSED WITH MULTIPLE VERTEBRAL METASTASES, BASED ON HER HISTORY OF LUNG CANCER AND THE RESULTS OF MAGNETIC RESONANCE IMAGING AND BONE SCINTIGRAPHY. THE PATIENT RECEIVED REGULAR RADIOTHERAPY TO TREAT THE METASTASES AND TOOK OPIOIDS TO RELIEVE HER PAIN. HOWEVER, HER PAIN COULD NOT BE RELIEVED AFTER 1 MONTH, WITH SEVERE EFFECTS ON HER SLEEP AND DAILY ACTIVITIES. HENCE, AN INDIVIDUALIZED PVP TREATMENT PLAN WAS DEVELOPED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389705 UNKNOWN KWP MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other