BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5179338 · Received October 27, 2015

    Report

    Report Number
    2953769-2015-00144
    Event Type
    Injury
    Date Received
    October 27, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 29, 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)(6). (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 A PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE (BKP) AT L3 TO TREAT VERTEBRAL COMPRESSION FRACTURE. THE PATIENT'S ANTERIOR LONGITUDINAL LIGAMENT WAS "CONNECTED" AT LEVELS TH11-L2 DUE TO DIFFUSED IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH). POST-OP, IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT DEVELOPED LOWER EXTREMITY PAIN DUE TO VERTEBRAL COLLAPSE OF L3 AND STENOSIS LED BY CEMENT MIGRATION IN THE VERTEBRAE. ON (B)(6) 2015, PATIENT UNDERWENT REVISION SURGERY TO PERFORM DECOMPRESSION AT L3 AND POSTERIOR FIXATION AT LEVELS 3-ABOVE 2-BELOW. PATIENT'S POST-REVISION COURSE WAS WELL. SURGEON COMMENTED THAT CRANIAL LEVELS THAT SUFFERED DISH MIGHT HAVE PULLED CRANIAL ENDPLATE OF L3 AND FRACTURE AT THE ENDPLATE WAS OCCURRED THAT RESULTED THE CEMENT MIGRATION. HE ALSO COMMENTED THAT BKP FOR THE PATIENT WHO HAD DISH WAS "DIFFICULT" BUT THOUGHT THE REVISION RECOVERED THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710323 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention