BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - CEMENT: VERTECEM V+

    MDR report key: 13791091 · Received March 17, 2022

    Report

    Report Number
    8030965-2022-01682
    Event Type
    Injury
    Date Received
    March 17, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT: VERTECEM V+/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TAKAHASHI, S. ET AL (2021), PERCUTANEOUS ENDOVASCULAR RETRIEVAL OF LARGE CEMENT LEAKAGE INTO THE RIGHT ATRIUM FOLLOWING CEMENT-AUGMENTED PEDICLE SCREW INSTRUMENTATION, SPINE SURGERY AND RELATED RESEARCH, VOL. 5 (6), PAGES 446-449 (JAPAN). THIS STUDY PRESENTS A CASE REPORT OF A (B)(6) YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH SEVERE BACK PAIN DUE TO OSTEOPOROTIC VERTEBRAL FRACTURE AT T12 WAS PLANNED FOR VERTEBRAL COLUMN RESECTION (VCR). A CEMENT-AUGMENTED FENESTRATED PEDICLE SCREW (CAPS) WAS PERFORMED USING EXPEDIUM VERSE¿ SPINAL SYSTEM AND VERTECEM V+¿ CEMENT (DEPUY SYNTHES PRODUCTS, INC., RAYNHAM, MA, USA). AFTER 4 MINUTES OF MIXING, THE BONE CEMENT WAS INSERTED INTO T10 PEDICLE SCREWS. A COUPLE OF MINUTES LATER, THE BONE CEMENT WAS INSERTED INTO L2. AT THIS POINT, THE SURGEONS OBSERVED LONG BONE CEMENT LEAKAGE FROM THE L2 PEDICLE IN FLUOROSCOPY (FIG. 2A), INTO THE VEIN (FIG. 2B). THE CEMENT GRADUALLY MOVED TO THE CRANIAL SIDE AND STOPPED AT THE LEVEL OF THE HEART, REQUIRING STOPPAGE OF THE SURGERY. AT THIS TIME, THERE WAS NO CHANGE IN BLOOD PRESSURE, HEART RATE, AND ELECTROCARDIOGRAM. THEY CONSULTED A RADIOLOGIST RESPONSIBLE FOR THE ENDOVASCULAR THERAPY. SIMULTANEOUSLY, HEPARIN WAS ADMINISTERED TO PREVENT THE FORMATION OF THROMBOSIS AROUND THE FOREIGN BODY AND SUBSEQUENT PULMONARY ARTERY EMBOLIZATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED THAT THE MIGRATED CEMENT REACHED INTO THE RIGHT ATRIUM AND TOUCHED THE INTERATRIAL SEPTUM (FIG. 2C). WE PLANNED TO REMOVE THE FREE CEMENT FRAGMENT USING A CATHETER IMMEDIATELY AFTER VCR TO AVOID THE RISK OF HEART WALL PERFORATION. THE RETRIEVAL OF THE MIGRATED CEMENT LINEAR FRAGMENT WAS SUCCESSFULLY PERFORMED USING A TRIPLE-LOOP SNARE. CONTRAST-ENHANCED CT TAKEN AFTER SURGERY REVEALED NO EVIDENCE OF PULMONARY EMBOLISM AND CARDIAC PERFORATION. THE PATIENT¿S BACK PAIN WAS RELIEVED AFTER SURGERY, AND NO FURTHER COMPLICATIONS OCCURRED. THIS REPORT IS FOR AN UNKNOWN SYNTHES VERTECEM V+ CEMENT. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292211 UNK - BIOMATERIAL - CEMENT: VERTECEM V+ POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention