BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R

    MDR report key: 1845747 · Received September 24, 2010

    Report

    Report Number
    2953769-2010-00462
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 31, 2007
    Report Date
    August 31, 2007
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED: "PROGRESSIVE, REPEATED LUMBAR COMPRESSION FRACTURE AT THE SAME LEVEL AFTER VERTEBRAL KYPHOPLASTY WITH CALCIUM PHOSPHATE CEMENT" JOURNAL OF NEUROSURGERY -SPINE 2007: 6 (6); 559-562 PUBLISHED BY DONG-HWA HEO M.D. AND COLLEAGUES (RESEARCHERS FROM YONSEI UNIVERSITY, SEOUL, KOREA). METHOD: DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED: "PROGRESSIVE, REPEATED LUMBAR COMPRESSION FRACTURE AT THE SAME LEVEL AFTER VERTEBRAL KYPHOPLASTY WITH CALCIUM PHOSPHATE CEMENT (CPC)", THE FOLLOWING EVENTS WERE REPORTED: A PHYSICIAN PERFORMED KYPHOPLASTY PROCEDURE ON A PATIENT AT LEVEL L1 USING CPC. TWO MONTHS POST PROCEDURE, THE PATIENT SUFFERED FROM SEVERE UPPER BACK PAIN, WHICH WAS THE SAME AS THE PREVIOUSLY EXISTING PAIN, AND EXPERIENCED PROGRESSIVE WEAKNESS OF BOTH LOWER EXTREMITIES (MOTOR STRENGTH GRADE 4/5). AT FIVE MONTHS POST PROCEDURE, A MORE SEVERE COMPRESSION OF THE L-1 VERTEBRA WAS REVEALED, AND THECAL SAC COMPRESSION CAUSED BY RETROBULGING OF THE CPC ON THE COLLAPSED L-1 VERTEBRA. THE AUTHORS PERFORMED DECOMPRESSION AND FUSION SURGERY TO TREAT THE REPEATEDLY COLLAPSED L-1 VERTEBRAE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT NDN MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other