BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 2597511 · Received May 29, 2012

    Report

    Report Number
    MW5025611
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    March 16, 2012
    Report Date
    May 29, 2012
    Manufacturer
    NDT, KYPHONE SUNNYVALE MFG.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING KYPHOPLASTY PROCEDURE, THE KYPHOPLASTY PRODUCT DID NOT FUNCTION PROPERLY, THE SHEATH DID NOT RETRACT, THEREFORE, THE CEMENT HARDENED PRIOR TO INSERTION. THE KYPON REP, (B)(4), WENT TO AN AREA OF STORAGE AND RETRIEVED AN OUTDATED PRODUCT, -FROM A CLOSED BOX WAITING FOR RETURN TO COMPANY- AND DISPERSED IT TO THE FIELD, WITHOUT CHECKING THE DATE ON THE PRODUCT. THE REP DID NOT FOLLOW HOSP POLICY AND PROCEDURE, HE SHOULD NEVER HAND PRODUCT TO THE STERILE FIELD. THE CIRCULATOR WAS UNAWARE OF THAT UNTIL SHE WENT TO DOCUMENT THE INFO. THE SURGEON WAS NOTIFIED AND PROCEDURE COMPLETED. INITIAL REPORT SUBMITTED BY MEDTRONICS MFR REPORT # 2953769-2012-00053. THIS IS BEING SUBMITTED TO CLARIFY THE EVENT THAT OCCURRED. SURGEON HAS FOLLOWED UP WITH PT, NO COMPLICATIONS NOTED AT THIS POINT. PT AWARE OF EVENT. DIAGNOSIS OR REASON FOR USE: COMPRESSION FRACTURE T12 L1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT NDN - CEMENT, BONE, VERTEBROPLASTY - RADIOPAQUE BONE CEMENT NDN NDT, KYPHONE SUNNYVALE MFG. NA EL21308

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR