BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON® HV-R® BONE CEMENT

    MDR report key: 23400609 · Received October 28, 2025

    Report

    Report Number
    2953769-2025-00065
    Event Type
    Injury
    Date Received
    October 28, 2025
    Report Date
    October 28, 2025
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    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

    B3: EVENT DATE IS UNKNOWN D4: LOT# IS UNKNOWN E1: INITIAL REPORTER DETAILS ARE UNKNOWN G2: COUNTRY OF EVENT IS JAPAN 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. 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION SPINAL THERAPY FOR REPLACEMENT OF L3, L4, S1 SCREWS AND EXTENSION OF FIXATION TO S2AI. INITIAL SURGERY HAPPENED ON (B)(6) 2025 FOR A PATIENT HAVING POSTERIOR FIXATION FROM L3/S1 FOR L3 COMPRESSION FRACTURE AND L5 BURST FRACTURE. FNSMAS WAS USED FOR L3, S1, AND SAS WAS USED FOR L4. REVISION SURGERY HAPPENED ON (B)(6) 2025. IT WAS REPORTED THAT THE CEMENT FROM S1 HAS LEAKED INTO THE SPINAL CANAL (BUT THERE IS NO PAIN ORIGINATING FROM THAT AREA). ADDITIONALLY, THE SCREW IN S1 HAS CUT OUT CAUDALLY. CEMENT REMAINS ON THE CRANIAL SIDE OF S1. IT IS PRESUMED THAT EVEN MORE STRESS WAS PLACED ON S1 BECAUSE THE PATIENT REFUSED TO WEAR A CORSET AFTER THE PREVIOUS SURGERY. THERE WAS UNKNOWN PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2795512 KYPHON® HV-R® BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG C01A-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention