BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE

    MDR report key: 20809215 · Received November 29, 2024

    Report

    Report Number
    6000033-2024-00047
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 29, 2024
    Manufacturer
    CARDIAC SURGERY MFG KERKRADE
    Product Code
    NDN
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS INDIA. G4 PMA/510(K)#: THE REPORTED PRODUCT C05B IS NOT MARKETED IN US BUT A SIMILAR PRODUCT WITH PRODUCT ID: CX01A, UDI: (B)(4) WITH 510(K)# K102397 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE PACK WAS OPENED, THE LIQUID MONOMER WAS FOUND IN A CRYSTALLIZED FORM, HENCE IT COULDN'T BE USED. THE EVENT OCCURRED DURING THE INITIAL SETUP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615504 KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE CEMENT, BONE, VERTEBROPLASTY NDN CARDIAC SURGERY MFG KERKRADE C05B 229547037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown