BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 2963570 · Received February 15, 2013

    Report

    Report Number
    1030489-2013-00510
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HT ZHANG, ZY SUN, XY ZHU, KW CHEN, ZL QIAN AND HL YANG. "KYPHOPLASTY FOR THE TREATMENT OF VERY SEVERE OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE". THE JOURNAL OF INTERNATIONAL MEDICAL RESEARCH 2012; 40: 2394 - 2400. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE STUDY INCLUDED 35 PATIENTS (21 WOMEN/14 MEN). DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4). 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 IN A RETROSPECTIVE STUDY OF 35 PATIENTS (TOTAL OF 49 VERTEBRAE; 21 WOMEN/14 MEN; AGE RANGE 62.0 - 83.0 YEARS) TREATED WITH BALLOON KYPHOPLASTY (BKP) FOR VERY SEVERE OSTEOPOROTIC VERTEBRAL COMPRESSION FRACUTRES (OVCF) WITH SEVERE PAIN, NONRESPONSIVE TO CONSERVATIVE MANAGEMENT, REPORTS SIGNIFICANT POSTOPERATIVE IMPROVEMENTS IN ALL CLINICAL AND RADIOLOGICAL OUTCOMES: VAS, ODI, VERTEBRAL HEIGHT RESTORATION, AND KYPHOTIC ANGLE THAT WERE MAINTAINED UP TO THE 1-YEAR FOLLOW-UP. FRACTURES WERE LOCATED BETWEEN T5 AND L5 (T5, 1; T6, 2; T7, 2; T8, 5; T9, 2; T10, 3; T11, 2; T12, 9; L1, 10; L2, 7; L3, 2; L4, 3; L5, 1). PATIENTS WERE FOLLOWED-UP POSTOPERATIVELY, AND AT 1 AND 3 MONTHS AND 1 YEAR AFTER SURGERY. ALL PATIENTS COMPLETED FOLLOW-UP. CEMENT LEAKAGE WAS EXAMINED BY FLUOROSCOPY DURING SURGERY AND BY POSTOPERATIVE CT SCAN. THE POSITION OF ANY CEMENT LEAKAGE WAS NOTED AND WAS CORRELATED WITH ANY SYMPTOMS REPORTED DURING THE FOLLO-UP PERIOD. IT WAS REPORTED THAT FOUR CEMENT LEAKS OCCURRED INTO THE PARAVERTEBRAL SOFT TISSUES AND ALL PATIENTS WERE ASYMPTOMATIC. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68201 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1