BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1920325 · Received December 10, 2010

    Report

    Report Number
    2953769-2010-00596
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 31, 2009
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "COMBINATION OF TRANSILIOSACRAL SCREW CONNECTION AND SACROPLASTY AS TREATMENT OF OSTEOPOROTIC PELVIC FRACTURES IN GERIATRIC PATIENTS", BY C. SCHMIDT, J. BOHME, S. GLASMACHER, T. BLATTERT, C. JOSTEN. METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "COMBINATION OF TRANSILIOSACRAL SCREW CONNECTION AND SACROPLASTY AS TREATMENT OF OSTEOPOROTIC PELVIC FRACTURES IN GERIATRIC PATIENTS", THE FOLLOWING WAS REPORTED: IN 2009, PATIENTS WITH TYPE-B-PELVIC-RING-FRACTURES WERE OPERATED. THE DIAGNOSIS IN ALL PATIENTS WAS BASED ON DETECTION OF ANTERIOR PELVIC RING FRACTURE IN CONVENTIONAL X-RAY, AND ADDITIONAL VERIFICATION OF TRANSALAR SACRUM FRACTURE IN COMPUTERTOMOGRAPHY. -11 PATIENTS THE PHYSICIAN OPERATED WITH UNILATERALLY OR BILATERALLY PERCUTANEOUS TRANSILISACRAL SCREWING. I -8 PATIENTS SACROPLASTY ADDITIONALLY WAS PERFORMED USING KYPHOPLASTY SET (MEDTRONIC 20) AFTER TRANSILIOSACRAL SCREW INSERTION. THE INSTILLED BONE CEMENT WAS BETWEEN 1.5 AND 5 ML. -COMPLICATIONS ASSOCIATED WITH OPERATION TECHNIQUE WAS FOUND - A CRANIAL CEMENT DISPLACEMENT IN ONE CASE WITHOUT FURTHER LESIONS ESPECIALLY WITHOUT LESION OF THE L5-NERVE ROOT. THE BONE CEMENT USED IN THESE PROCEDURES WAS NOT IDENTIFIED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR