BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON® HV-R® BONE CEMENT

    MDR report key: 23905538 · Received December 29, 2025

    Report

    Report Number
    3003120897-2025-00810
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 27, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    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

    B5: EVENT PROBLEM DESCRIPTION IS UPDATED B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS PULMONARY EMBOLISM RESULTED IN EXTENDED HOSPITALIZATION, THUS REPORTABILITY HAS BEEN UPDATED FROM MALFUNCTION TO SERIOUS INJURY. 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

    G4: PLEASE NOTE THAT THIS DEVICE (C01A-J) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SAME AS THE UNITED STATES MARKETED DEVICE WITH CATALOG# C01A, 510K# K041584 AND UDI# (B)(4). H6: 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. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS POSTERIOR SPINAL FIXATION AND PERCUTANEOUS VERTEBROPLASTY. THE PATIENT WAS TRANSFERRED TO A NEARBY HOSPITAL DUE TO PULMONARY EMBOLISM. VITALS WERE STABLE. IT WAS BELIEVED THAT THE HOSPITAL TRANSFER RESULTED IN AN EXTENSION OF THE HOSPITAL STAY. THE LEAK ISSUE MOST LIKELY HAPPENED DUE TO A PROCEDURAL ISSUE AND SCREW DOESN'T HAVE ANY OTHER MALFUNCTION, JUST IT GOT LEAKED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION/ALLEGATION AGAINST THE SCREW.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS L1 FRACTURE. IT WAS REPORTED THAT THE DURING A SPINAL PROCEDURE FOR THE L1 FRACTURE, 2-2  FIXATION WAS PERFORMED AND SCREWS WERE INSERTED INTO THE AFFECTED VERTEBRA. BONE CEMENT WAS INJECTED AS PART OF THE PROCEDURE, BUT THE CEMENT WAS LEAKED INTO THE SEGMENTAL VEIN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917716 KYPHON® HV-R® BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC. C01A-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown