BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5465979 · Received February 29, 2016

    Report

    Report Number
    2953769-2016-00013
    Event Type
    Injury
    Date Received
    February 29, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 21, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K041584 WAS CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: VERTEBRAL BODY FRACTURE AT L4-5 (L4: BKP) (L4/5: POSTERIOR FUSION, NON-MEDTRONIC) PROCEDURE: BALLOON KYPHOPLASTY (BKP) AND POSTERIOR FUSION (PF) LEVELS: L4-5 IT WAS REPORTED ON (B)(6) 2016, INTRA-OP, THERE WAS A POSSIBILITY THAT CEMENT LEAKED INTO THE BLOOD VESSEL. SURGEON COMMENTED THAT IT COULD NOT BE CONCLUDED BUT THE POSSIBILITY IS HIGH. THE ROOM TEMPERATURE OF THE AIR-CONDITIONING WAS 20 DEGREES BUT REP REPORTED THAT HE FELT SLIGHTLY HIGHER "BECAUSE ENTRANCE DOOR WAS OPEN". SURGEON STARTED FILLING CEMENT 9MINS EARLIER THAN USUAL BECAUSE HE HAD SCHEDULED TO INSERT SCREW (PPS) IMMEDIATELY AFTER PERFORMING BKP SURGERY AT L4. WHEN SURGEON CHECKED CEMENT VISCOSITY BEFORE INJECTION, THE CEMENT "FORMED THREADS", BUT SURGEON DETERMINED THAT IT WAS ACCEPTABLE TO ACCOUNT FOR THE WORKING TIME TO FILL THE CEMENT AFTER SHRINKING THE BALLOON. BALLOON INFLATED ABOUT 3.5MM. NO ABNORMALITY THAT SUGGEST CEMENT LEAKAGE OBSERVED WHEN IT WAS FILLED WITH FIRST BFD SYRINGE. AT AROUND THE SECOND HALF OF THE SECOND SYRINGE OF FILLING, IT SEEMED CEMENT LEAKED IN THE X-RAY. FILLING WAS ABORTED IMMEDIATELY. AFTER THAT SURGEON INSERTED SCREW AND SURGERY WAS COMPLETED. DURING SURGERY, NO CONDITION CHANGE IN THE PATIENT WAS OBSERVED. IT COULD NOT BE CONCLUDED WHETHER CEMENT LEAKED INTO THE VESSEL BUT SURGEON WILL OBSERVE POSTOPERATIVE COURSE AND TAKE CT IMAGE. THE LOCATION OF SUSPECTED IS CENTER OF VERTEBRAL BODY RATHER CAUDAL SIDE FROM RIGHT LATERAL SIDE. THE SURGEON COMMENTED THAT HE WILL TAKE THE CT IMAGE AFTER SURGERY AND OBSERVED THE POSTOPERATIVE COURSE. POST-OP CT OF AP-VIEW CONFIRMED THAT CEMENT LEAKED AROUND 2CM FROM RIGHT LATERAL INTO THE BLOOD VESSEL. DETAILS ON THE BLOOD VESSEL ARE UNKNOWN. CHEST CT WAS NOT TAKEN. POST-OP, THE PATIENT WAS NOT ABLE TO PUT RIGHT ARM UP, THEN IT RECOVERED. DR. TOLD THAT A ROOT CAUSE COULD NOT BE DETERMINED AND THERE WAS NO ISSUE AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125261 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL51214

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Other