BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MEDTRONIC IMPLANT

    MDR report key: 2571613 · Received May 11, 2012

    Report

    Report Number
    1030489-2012-00616
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    February 1, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: ZAFEIRIS ET AL. HYPOVITAMINOSIS D AS A RISK FACTOR OF SUBSEQUENT VERTEBRAL FRACTURES AFTER KYPHOPLASTY. THE SPINE JOURNAL 2012 FEBRUARY AVERAGE AGE OF PARTICIPANTS: (B)(6), FEMALES: 40, MALES: 58. (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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT A PROSPECTIVE LONGITUDINAL CLINICAL STUDY WAS CONDUCTED OF FORTY POSTMENOPAUSAL WOMEN WITH PRIMARY OSTEOPOROSIS AND ACUTE SYMPTOMATIC VERTEBRAL COMPRESSION FRACTURES WITH STABLE OR DETERIORATIVE PAIN FOR UP TO 12 WEEKS. THE MEAN POPULATION AGE WAS (B)(6) (RANGE 40-83 YEARS). AGE, BODY MASS INDEX, HISTORY OF TOBACCO USE, NUMBER OF INITIAL VERTEBRAL FRACTURES, INTRADISCAL CEMENT LEAKAGE, HISTORY OF NONSPINAL FRACTURES, USE OF ANTIOSTEOPOROTIC MEDICATIONS, BONE MINERAL DENSITY, BONE TURN OVER MARKERS, AND 25 (OH)D LEVELS WERE ASSESSED. ALL PARTICIPANTS WERE EVALUATED CLINICALLY AND/OR RADIOGRAPHICALLY. A TOTAL OF NINETY-EIGHT KYPHOPLASTIES WERE PERFORMED ON THE 40 FEMALE PATIENTS. KYPHOPLASTY WAS PERFORMED THROUGH STANDARD BILATERAL TRANSPEDICULAR APPROACH UNDER GENERAL ANESTHESIA. THE MOST COMMONLY TREATED VERTEBRAE WERE T12, T11, AND L1 WITH 19, 17, 16 FRACTURES, RESPECTIVELY. FOLLOW-UP PERIOD WAS 18 MONTHS. NINE OF THE BKP PATIENTS (22.5%) DEVELOPED A POSTKYPHOPLASTY VERTEBRAL COMPRESSION FRACTURE. THE NEW FRACTURES OCCURRED IN 11 LEVELS: NINE WERE ADJACENT TO THE KYPHOPLASTY LEVEL, WHEREAS THE REMAINING TWO OCCURRED IN A REMOTE VERTEBRA (A REMOTE LEVEL IS DEFINED AS A LEVEL WITH AT LEAST ONE UNAFFECTED LEVEL BETWEEN THE INITIALLY TREATED FRACTURE AND THE SUBSEQUENT ONE). INTRADISCAL CEMENT LEAKAGE WAS IDENTIFIED IN SEVEN PATIENTS (17.5%), WITH 3 (33.3%) IN THE GROUP WITH RECURRENT FRACTURES AND 4 IN THE NON-FRACTURE GROUP (12.9%), RESPECTIVELY. THE GROUP WITHOUT RECURRENT FRACTURES DEMONSTRATED STATISTICALLY SIGNIFICANT HIGHER LEVELS OF 25-HYDROXYVITAMIN (OH) D OF 22.6±5.5 VS.14.4±7.5 IN THE FRACTURE GROUP. BONE METABOLISM AND 25(OH)D LEVELS SEEM TO PLAY A ROLE IN THE OCCURRENCE OF POSTKYPHOPLASTY RECURRENT VERTEBRAL COMPRESSION FRACTURES. ALL FEMALE PATIENTS HAD BALLOON KYPHOPLASTY IMPLANTED: 7 PATIENTS HAD INTRADISCAL CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC IMPLANT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention