BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CH HORIZON SPINAL SYSTEM

    MDR report key: 11054326 · Received December 22, 2020

    Report

    Report Number
    1030489-2020-01833
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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: CEMENT EMBOLISM IN THE VENA CAVA AFTER PEDICLE SCREW AUGMENTATION. DER UNFALLCHIRURG: KASUISTIKEN. 2020. ISSUE# UNK. SUMMARY: AFTER A FALL, THE PATIENT SUFFERED AN UNSTABLE FRACTURE OF LUMBAR VERTEBRAL BODY 3 AND A STABLE FRACTURE OF THORACIC VERTEBRAL BODY 12 WITHOUT NEUROLOGICAL DEFICITS. IN ADDITION TO THE BALLOON KYPHOPLASTY OF THORACIC VERTEBRAL BODY 12, PERCUTANEOUS FIXATOR INTERNAL INSTRUMENTATION OF LUMBAR VERTEBRAL BODIES 2¿4 WAS CARRIED OUT WITH CEMENT-AUGMENTED PEDICLE SCREWS (CD HORIZON LONGITUDE; MEDTRONIC, DUBLIN, IRELAND). CEMENT LEAKAGE INTO THE INFERIOR VENA CAVA OCCURRED. AFTER THE ONSET OF DETACHMENT OF THE CEMENT PARTS, THEY DECIDED ON AN ENDOVASCULAR REMOVAL USING THE SLING TECHNIQUE. THE POSTINTERVENTIONAL COURSE WAS UNCOMPLICATED. REPORTED EVENTS: 1. PATIENT PRESENTED WITH LUMBAR BACK PAIN AFTER FALLING DOWN THE STAIRS THE PREVIOUS DAY; THERE WERE NO NEUROLOGICAL DEFICITS. X-RAY AND COMPUTED TOMOGRAPHY (CT) SHOWED A STABLE FRACTURE [INCOMPLETE BURST FRACTURE] OF THE THORACIC VERTEBRAL BODY 12 AND AN UNSTABLE FRACTURE [COMPLETE BURST FRACTURE] OF THE LUMBAR VERTEBRAL BODY 3. 2. THEY RECOMMENDED KYPHOPLASTY OF THORACIC VERTEBRAL BODY 12 AND STABILIZATION OF LUMBAR VERTEBRAL BODY 3 WITH AN INTERNAL FIXATOR FROM LUMBAR VERTEBRAL BODY 2 TO LUMBAR VERTEBRAL BODY 4. SURGICAL TREATMENT WAS PERFORMED ON THE DAY OF ADMISSION. AFTER UNCOMPLICATED KYPHOPLASTY OF THORACIC VERTEBRAL BODY 12, CLOSED REDUCTION AND PERCUTANEOUS INTERNAL FIXATOR STABILIZATION OF LUMBAR VERTEBRAL BODY 3 WITH AUGMENTATION OF THE 4 CANNULATED/PERFORATED PEDICLE SCREWS (CD HORIZON LONGITUDE; MEDTRONIC, DUBLIN, IRELAND) WITH 1.5ML LOW-VISCOSITY CEMENT EACH WERE PERFORMED. 3. BEFORE THE CEMENT WAS PRESSED IN VIA THE BONE FILLER, AS RECOMMENDED, IT WAS WAITED 6 MIN UNTIL THE CEMENT HAD REACHED A VISCOUS CONSISTENCY. THIS WAS DONE UNDER PULSED IMAGE CONVERTER CONTROL, 1.5 ML OF CEMENT (OSTEOPAL V, HERAEUS, HANAU, GERMANY) WAS USED FOR EACH SCREW; THE CEMENT DISTRIBUTION APPEARED IN THE DESIRED LOCATION. 4. ONLY AFTER COMPLETION OF THE CEMENTING PROCESS WAS THERE A VENTRAL-CRANIAL LEAKAGE OF 2 CEMENT FLAGS THROUGH THE PEDICLE SCREW TIPS IN LUMBAR VERTEBRAL BODY 2 AND 4, APPARENTLY VIA VENOUS CONNECTIONS INTO THE VENA CAVA. 5. AFTER FINAL X-RAY DOCUMENTATION, THE SOFT TISSUES WERE CLOSED AND ANESTHESIA WAS WITHDRAWN. THERE WERE NO NEUROLOGICAL DEFICITS OR CLINICAL INDICATIONS OF PULMONARY EMBOLISM POSTOPERATIVELY 6. THE POSTOPERATIVE CT OF THE LUMBAR SPINE CONFIRMED THE SUSPECTED CEMENT EMBOLISM. IT ORIGINATED FROM THE RIGHT PEDICLE SCREWS IN LUMBAR VERTEBRAL BODY 2 AND 4 AND ENTERED THE INFERIOR VENA CAVA VIA PARAVERTEBRAL VEINS. THE SCREW POSITION AND FRACTURE REDUCTION WERE REGULAR. THE CEMENT FLAGS WERE CONNECTED TO THE VERTEBRAL BODIES. THERE WERE NO CLINICAL SYMPTOMS OF CEMENT PULMONARY EMBOLISM. THROMBOSIS PROPHYLAXIS WAS GIVEN WITH DALTEPARIN 5000 I.U. ONCE DAILY. 7. AFTER DISCUSSION, AN INTERVENTION TO REMOVE THE CEMENT WAS ALSO POSTPONED BECAUSE THE PATIENT WAS COMPLETELY SYMPTOM-FREE. A CT SCAN OF THE LUMBAR SPINE, THORAX AND ABDOMEN WAS RECOMMENDED TO MONITOR PROGRESS AND EXCLUDE A CEMENT EMBOLISM. 8. THIS CT WITH CONTRAST MEDIUM 5 WEEKS AFTER THE SURGERY NOW SHOWED A PARTIAL DISPLACEMENT OF THE CEMENT STRANDS TOWARDS THE CENTER. SOME OF THE CEMENT TIPS WERE CAUGHT IN THE VESSEL WALL; SMALL CEMENT PARTICLES WERE ALSO FOUND IN THE LUNG. 9. IN ORDER TO PREVENT FURTHER EMBOLISM, VASCULAR OR CARDIAC INJURY CAUSED BY LARGER CEMENT PARTICLES, THE PATIENT WAS NOW RECOMMENDED ENDOVASCULAR REMOVAL OF THE CAVAL CEMENT REMNANTS. THIS PROCEDURE WAS PERFORMED 2 MONTHS AFTER SURGICAL INTERVENTION IN THE HYBRID OR UNDER ANALGESIA AND ANESTHESIA. 10. REMOVAL OF THE CEMENT EMBOLIZED INTO THE LUNGS WAS NOT SUCCESSFUL. THE POSTOPERATIVE COURSE WAS UNREMARKABLE. THERE WERE NO NEUROLOGICAL DEFICITS OR CLINICAL SIGNS OF PULMONARY EMBOLISM. THE PATIENT WAS FULLY ABLE TO EXERCISE UNDER MILD PAIN MEDICATION. DISCUSSION: 1. THEY DECIDED TO PERFORM MINIMALLY INVASIVE INTERNAL FIXATOR STABILIZATION WITH CEMENT AUGMENTATION IN THE CASE OF AN UNSTABLE FRA CTURE OF THE LUMBAR VERTEBRAL BODY 3, WHICH RESULTED IN CEMENT LEAKAGE VIA THE SCREW TIPS INTO THE INFERIOR VENA CAVA. 2. CEMENT LEAKAGE DURING VERTEBRAL AUGMENTATION (VERTEBROPLASTY, KYPHOPLASTY, SCREW AUGMENTATION) IS A SERIOUS COMPLICATION; ACCORDING TO THE LITERATURE. 3. IN ORDER TO PREVENT CEMENT LEAKAGE DURING PEDICLE SCREW AUGMENTATION, IT IS RECOMMENDED TO CEMENT THE SCREWS IN DIFFERENT VERTEBRAL BODIES, IN ADDITION TO REDUCED CEMENT QUANTITIES (MAXIMUM 1-1.5 ML) AND WAITING FOR SUFFICIENT CEMENT VISCOSITY, IN ORDER TO BE ABLE TO BETTER ASSESS THE CEMENT DISTRIBUTION OF THE INDIVIDUAL SCREW UNDER IMAGE INTENSIFICATION AND TO AVOID INTRAVERTEBRAL PRESSURE PEAKS. IN OUR CASE, DESPITE A CAREFUL PROCEDURE, A CEMENT EMBOLISM OCCURRED INTRAOPERATIVELY AND WAS ONLY DETECTED AT THE END OF THE OPERATION. TO PREVENT EMBOLISM OF LARGER CEMENT DEBRIS INTO THE HEART OR LUNGS, THEY DECIDED TO REMOVE THE LARGEST CEMENT DEBRIS BY A MINIMALLY INVASIVE ENDOVASCULAR PROCEDURE. CONCLUSION: WHEN CEMENT AUGMENTATION OF INTERNAL FIXATOR PEDICLE SCREWS IS PERFORMED, THE RISK OF LEAKAGE INTO THE PARAVERTEBRAL VENOUS PLEXUS AND SUBSEQUENTLY THE VENA CAVA WITH THE THREAT OF EMBOLISM MUST BE CONSIDERED. A POSTOPERATIVE CT SCAN OF THE VERTEBRAL BODIES INCLUDED IN THE INSTRUMENTATION SHOULD ALWAYS BE PERFORMED; IF CEMENT LEAKAGE IS SUSPECTED, A CT OF THE THORAX AND ABDOMEN WITH CONTRAST MEDIUM IS RECOMMENDED FOR DIAGNOSTIC PURPOSES. AFTER WEIGHING THE ADVANTAGES AND DISADVANTAGES, AN ENDOVASCULAR PROCEDURE IS A TREATMENT OPTION FOR REMOVING INTRAVASCULAR CEMENT REMNANTS. THE PATIENT'S MEDICAL HISTORY INCLUDED OSTEOPOROSIS TREATED WITH MEDICATION FOR LONG-TERM NICOTINE ABUSE AND A CARDIAC SEPTAL DEFECT AS A SMALL CHILD THAT WAS NOT KNOWN IN DETAIL AND HAD BEEN TREATED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521117 CH HORIZON SPINAL SYSTEM KWP MDT SOFAMOR DANEK PUERTO RICO MFG MSB_UNK_HDWR_CDH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention