BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5591646 · Received April 20, 2016

    Report

    Report Number
    2953769-2016-00031
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 22, 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

    PMA 510(K): 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, BALLOON KYPHOPLASTY SURGERY WAS PERFORMED FOR COMPRESSION FRACTURE AND THE PATIENT WAS MAKING STEADY PROGRESS. ABOUT ONE MONTH FROM THE SURGERY ON (B)(6) 2016, THE PATIENT DEVELOPED LOW BACK PAIN. X-RAY REVEALED THAT CEMENT WAS MIGRATED TO ANTERIOR. CEMENT WAS RECEDED IN SUPINE POSITION AND A RIGHT SIDE CHUNK OF CEMENT WAS MOVED TO ANTERIOR IN SITTING POSITION. THE LOW BACK PAIN WAS CONSIDERED TO COME UP BECAUSE CEMENT WAS MOVING IN THE VERTEBRAL BODY. PATIENT COMPLICATIONS WERE REPORTED. OSTEOPOROTIC VERTEBRAL FRACTURE (OVF) AT T12 WAS OBSERVED BUT THE CAUSE OF THE FRACTURE WAS UNKNOWN. IN ADDITION TO T12, THERE WAS EXISTING FRACTURE OF THE TWO VERTEBRAL BODIES. THE CAUSE OF THE CEMENT MIGRATION IS UNKNOWN. THE PATIENT HAD NO CO-MORBIDITIES OTHER THAN OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248467 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL51214

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Other