BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1934953 · Received December 21, 2010

    Report

    Report Number
    2953769-2010-00611
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "A SIMPLE INTRAOPERATIVE POSITION DETERMINATION METHOD DURING BALLOON KYPHOPLASTY IN PATIENTS WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AND MIMICS 3-DIMENSIONAL RECONSTRUCTION EVALUATION TO TRANSPEDICULAR TROCARS CHANNEL AND CEMENT LEAKAGE", BY JUN ZHOU, HUILIN YANG, WEN ZHANG, ZONGPING LUO, XIN MEI. DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Additional Manufacturer Narrative · 1

    SENDING SUPPLEMENTAL REPORT DUE TO EMDR TRANSMISSION ISSUE WITH INITIAL SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "A SIMPLE INTRAOPERATIVE POSITION DETERMINATION METHOD DURING BALLOON KYPHOPLASTY IN PATIENTS WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AND MIMICS 3-DIMENSIONAL RECONSTRUCTION EVALUATION TO TRANSPEDICULAR TROCARS CHANNEL AND CEMENT LEAKAGE", THAT: BETWEEN (B)(6) 2007 AND (B)(6) 2010, 63 OVCFS IN 42 PATIENTS BETWEEN L1 AND L5 WERE TREATED BY BALLOON KYPHOPLASTY. -ONLY 1 CEMENT LEAKAGE WAS OBSERVED. NO FURTHER INFORMATION WAS REPORTED. IT IS UNKNOWN IF THE BONE CEMENT USED WAS HV-R. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1