BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON® HV-R® BONE CEMENT

    MDR report key: 22531571 · Received July 17, 2025

    Report

    Report Number
    1030489-2025-02455
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 23, 2025
    Report Date
    February 12, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    UDI-DI
    00643169097872
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1: UPDATED B5: ADDITIONAL INFORMATION RECEIVED H1: UPDATED ADDITONAL CODES UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS JAPAN. G4: THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH PRODUCT NUMBER C01A WITH 510(K)# K041584 AND UDI (B)(4) IS MARKETED IN US. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6), A CEMENT REMOVAL CASE WAS PERFORMED AT THE DEPARTMENT OF CARDIOVASCULAR SURGERY. IT IS SAID THAT THE CEMENT OF THIS EVENT CRACKED AND SEPARATED INTO TWO AROUND 3 MONTHS AFTER THE OPERATION. AFTER THAT, NO CEMENT MOVEMENT WAS OBSERVED, AND THE PATIENT'S CONDITION DID NOT CHANGE (ASYMPTOMATIC). AS A RESULT OF CONSULTING WITH THE CARDIOVASCULAR SYSTEM, A CEMENT REMOVAL CASE WAS PERFORMED ON (B)(6). AN IVC FILTER WAS INSTALLED AND CEMENT WAS REMOVED USING A SNARE, BUT THE CEMENT WAS ADHERED TO AND SEVERAL ATTEMPTS WERE MADE TO REMOVE IT, BUT THE CEMENT DID NOT MOVE AND COULD NOT BE REMOVED, AND OPE WAS TERMINATED. AFTER SURGERY, PATIENTS CONTINUE TO RECEIVE ANTICOAGULANTS, ALTHOUGH THEY ARE ASYMPTOMATIC. THE CEMENT COULD NOT BE REMOVED. THE PATIENT IS CONTINUING TO RECEIVE ANTICOAGULANT THERAPY. IT WAS PREVIOUSLY STATED THAT ANTICOAGULANT MEDICATION WAS CONTINUED; HOWEVER, THE CORRECT INFORMATION IS THAT NO MEDICATION WAS ADMINISTERED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BALLOON KYPHOPLASTY (BKP) FOR SECONDARY FRACTURE (COMPRESSION FRACTURE). IT WAS REPORTED THAT DURING THE INJECTION OF 0.8CC OF FNS CEMENT INTO THE RIGHT SIDE OF L2, EXTRA VERTEBRAL LEAKAGE WAS IDENTIFIED THROUGH INTRAOPERATIVE FLUOROSCOPY. POSTOPERATIVE CT IMAGING REVEALED THAT THE CEMENT HAD REACHED THE INFERIOR VENA CAVA. IT HAS BEEN CONFIRMED THAT THE PATIENT IS ASYMPTOMATIC AT THIS TIME; HOWEVER, AFTER CONSULTING WITH THE CARDIOLOGY DEPARTMENT, ANTICOAGULANT THERAPY WILL BE INITIATED TO PREVENT PULMONARY EMBOLISM. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MALFUNCTION IS REPORTED WITH UNKNOWN VOYAGER IMPLANT. IT WAS ADDED TO THIS EVENT FOR A VERTEBRAL FRACTURE POST INITIAL SURGERY. THE CEMENT LEAKED FROM THE VOYAGER FENESTRATED SCREW. THERE WERE NO MALFUNCTIONS WITH FNS TIPS AND BONE FILLER DEVICES. THEY WERE USED ALONG WITH FENESTRATED SCREW. THERE ARE NO DEFECTIVE EVENTS SUCH AS DEFORMATION OF THE PRODUCT. THERE IS NO PRODUCT MALFUNCTION FROM THE INITIAL SURGERY. THERE WAS NO RELATION BETWEEN VERTEBRAL FRACTURE AND THE EXPLANTED UNKNOWN VOYAGER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808670 KYPHON® HV-R® BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC C01A-J EL70348 00643169097872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown