BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® HV-R® BONE CEMENT

    MDR report key: 22103704 · Received May 29, 2025

    Report

    Report Number
    1030489-2025-02110
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 29, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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), 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING T H10 ANTEROPOSTERIOR SIMULTANEOUS FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH RUPTURE FRACTURE. IT WAS REPORTED THAT THERE WAS CEMENT LEAKAGE FROM THE CONNECTION BETWEEN FNS MAS AND CDD. AFTER INJECTING THE FOUR HEAD-SIDE CEMENTS, INJECT THE FOUR TAIL-SIDE CEMENTS. THE CDD WAS REMOVED IN CONJUNCTION WITH THE CEMENT HARDENING OF THE 4 HEAD-SIDE UNITS. THE CDD ON THE TH10 RIGHT SIDE IS HARD; WHEN IT IS PULLED AND REMOVED, THE GUIDE TIP REMAINS. CEMENT LEAKAGE WAS CONFIRMED WHEN THE SURGICAL FIELD WAS CHECKED (DEPLOYMENT WAS AN INTERMUSCULAR APPROACH). THE GUIDE TIP WAS RE-ATTACHED TO THE DELIVERY DEVICE AND EXPLANTED. THE SURROUNDING CEMENT WAS EXTRACTED WITH A PUNCH. EVERYTHING WAS REMOVED, AND IT WAS CONFIRMED THAT THERE WAS NO CEMENT REMAINING IN THE CROWN/A SCREW DRIVER WAS ATTACHED, AND THAT IT FITS THE TORQUE. THE SCREW WAS USED AS IS AND THE ROD WAS TIGHTENED AND FINALLY TIGHTENED AT THE PHYSICIAN'S DISCRETION. THERE WAS A DELAY OF LESS THAN 60 MINS. 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
    674029 KYPHON® HV-R® BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC C01A-J EL70345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown