BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON KURVE BONE FILLER DEVICE 13GA

    MDR report key: 10269352 · Received July 14, 2020

    Report

    Report Number
    9612164-2020-02567
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    July 13, 2020
    Report Date
    November 6, 2020
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    KIH
    UDI-DI
    00763000026783
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #703848431:PART # VPT02A LOT # 219060536 VISUAL AND OPTICAL INSPECTION REVEALED A PORTION OF THE TIP OF THE CURVED NEEDLE HAS BROKEN OFF. THE FRACTURE EDGES ARE SLIGHTLY ANGLED AND RIGID. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH INDICATION OF OSTEOPOROSIS FOR SPINAL THERAPY. THE EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THE CURVE WAS INSIDE VERTEBRAL BODY WHEN THE SNAP WAS HEARD BY DOCTOR. THE BONE WAS SUPER SOFT WITHOUT SCLEROTIC POCKETS. THE DOCTOR WASN'T TWISTING IT AROUND OR DOING ANYTHING THAT WOULD CAUSE STRESS ON THE METAL. HE WAS ADVANCING IT THROUGH VERY SOFT BONE. AFTER THE SNAP WAS HEARD, HE PULLED IT OUT AND THE CURVE WAS BROKEN AT THE TIP HOLDING TOGETHER BY A THREAD AND CAME APART AS SOON AS IT WAS OUT OF THE CANNULA. HCP WAS DEMANDING A FULL REPORT TO BE PROVIDED TO HIM. PRODUCT WILL BE RETURNED BACK. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED. PROCEDURE PLANNED WAS KYPHOPLASTY.

    Additional Manufacturer Narrative · 1

    SIMILAR DEVICE 510K: K070527; K063248. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH INDICATION OF OSTEOPOROSIS FOR SPINAL THERAPY. THE EVENT OCCURRED INTRA-OP. PATIENT DEMOGRAPHICS: (B)(6). IT WAS REPORTED THAT THE CURVE WAS INSIDE VERTEBRAL BODY WHEN THE SNAP WAS HEARD BY DOCTOR. THE BONE WAS SUPER SOFT WITHOUT SCLEROTIC POCKETS. THE DOCTOR WASN'T TWISTING IT AROUND OR DOING ANYTHING THAT WOULD CAUSE STRESS ON THE METAL. HE WAS ADVANCING IT THROUGH VERY SOFT BONE. AFTER THE SNAP WAS HEARD, HE PULLED IT OUT AND THE CURVE WAS BROKEN AT THE TIP HOLDING TOGETHER BY A THREAD AND CAME APART AS SOON AS IT WAS OUT OF THE CANNULA. HCP WAS DEMANDING A FULL REPORT TO BE PROVIDED TO HIM. PRODUCT WILL BE RETURNED BACK. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733800 KYPHON KURVE BONE FILLER DEVICE 13GA DISPENSER, CEMENT KIH MEDTRONIC MEXICO VPT02A 219060536 00763000026783

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR