BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5149638 · Received October 14, 2015

    Report

    Report Number
    2953769-2015-00140
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    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)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # C01A AND 510K # K041584 OF 'LIKE DEVICES' 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

    IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) TO TREAT COMPRESSION FRACTURE AT LEVEL T11. CEMENT WAS INJECTED EACH 3 MM ON THE BOTH SIDE ALTERNATELY. CEMENT LEAKAGE INTO THE SPINAL CANAL WAS OBSERVED DURING SECOND RIGHT INJECTION. CT INSPECTION WAS CONDUCTED AFTER CLOSING INCISION AND DECOMPRESSION SURGERY WAS OPERATED. CEMENT PROBABLY LEAKED FROM THE POSTERIOR WALL NEAR THE CENTER OF THE VERTEBRAL BODY. REVISION SURGERY WAS CONDUCTED AT THE SAME DAY AS INITIAL SURGERY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680352 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL50614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BKP KIT