BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHON

    MDR report key: 8517594 · Received April 16, 2019

    Report

    Report Number
    1030489-2019-00422
    Event Type
    Death
    Date Received
    April 16, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 16, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PRODUCTS WERE INVOLVED IN THE EVENT. ALTHOUGH IT IS UNKNOWN WHICH OF THE PRODUCTS LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: VPK1003, LOT: WI564235, QTY: 3, EXEMPT; PRODUCT ID: VPT01B, LOT: 216815007, QTY: 3, EXEMPT; PRODUCT ID: CX01B, LOT: 0009623617, QTY: 2, 510K#: K102397, UDI: (B)(4). OCCUPATION: INITIAL REPORTER: PATIENT. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AT T9, T12, L1 AND L3 PROCEDURE: VERTEBROPLASTY OF T9, T12, L1 AND L3 IT WAS REPORTED THAT INTRA-OP, THE PATIENT DIED AT THE END OF VERTEBROPLASTY PROCEDURE, AFTER CEMENT WAS IMPLANTED. THE PROCEDURE WAS A ROUTINE 4 LEVEL VERTEBROPLASTY OF LEVELS T9, T12, L1 AND L3. THERE WERE NO COMPLICATIONS THROUGHOUT ACCESS AND CEMENT IMPLANTING, NO CEMENT EXTRAVASATION OR VEINOUS LEAK. AFTER CEMENTING FOURTH LEVEL, PHYSICIAN REQUESTED ADDITIONAL CEMENT TO BE MIXED AND IMPLANTED. THE SALES REP WENT TO GET ANOTHER CEMENT UPON THE RETURN THE ROOM WAS FILLED WITH THE CODE TEAM. PATIENT HAD CRASHED AND WAS FLIPPED OFF OPERATING TABLE ONTO HOSPITAL BED. CODE TEAM WORKED ON HER FOR 32 MINUTES, THE PATIENT WAS DETERMINED DECEASED. THE PHYSICIAN DID NOT THINK IT WAS LIDO TOXICITY, NOR CEMENT TOXICITY. ABOUT 20CC CEMENT WAS IMPLANTED, AND ESTIMATED DURATION OF PROCEDURE ABOUT ONE HOUR AND 15 MINUTES. NO ADVERSE EVENTS WERE RELATED TO THE PRODUCT. NO PRODUCT MALFUNCTION OCCURRED. PATIENT DEATH FOLLOWED CODE BLUE AT THE END OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311985 KYPHON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O