BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 6773029 · Received August 8, 2017

    Report

    Report Number
    1030489-2017-01872
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ZHI-YONG SUN, XUE-FENG LI, HUAN ZHAO, JUN LIN, ZHONG-LAI QIAN, ZHI-MING ZHANG, HUI-LIN YANG; "PERCUTANEOUS BALLOON KYPHOPLASTY IN TREATMENT OF PAINFUL OSTEOPOROTIC OCCULT VERTEBRAL FRACTURE: A RETROSPECTIVE STUDY OF 89 CASES" MEAN AGE: 67.5±11.5 ( RANGE: 56-79 YEARS) 55 FEMALE AND 34 MALE (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BETWEEN 2011 AND 2013, 89 PATIENTS SUFFERING FROM PAINFUL OOVFS( OCCULT OSTEOPOROTIC VERTEBRAL FRACTURES) UNDERWENT 142 PERCUTANEOUS BALLOON KYPHOPLASTY (PKP) PROCEDURES. OUTCOME DATA (MEAN VARIATION OF ANTERIOR AND MIDDLE VERTEBRAL BODY HEIGHT, VISUAL ANALOG SCALE [VAS] SCORES, OSWESTRY DISABILITY INDEX [ODI] SCORES, AND SF-36 SCORES) WERE RECORDED PREOPERATIVELY, POSTOPERATIVELY, AND AT 1 MONTH, 6 MONTHS, AND 2 YEAR AFTER TREATMENT, TO EVALUATE THE RESULTS. WE SUCCESSFULLY TREATED 89 PATIENTS (142 VERTEBRAL BODIES) WITH PKP. THE MEAN VARIATION OF ANTERIOR AND MIDDLE VERTEBRAL BODY HEIGHT CHANGED FROM 96.5±3.4% PREOPERATIVELY TO 97.2±2.5% POSTOPERATIVELY (P>0.05) AND FROM 96.3±2.8% PREOPERATIVELY TO 97.9±3.1% POSTOPERATIVELY (P>0.05), RESPECTIVELY. THE MEAN VAS SCORES WERE REDUCED SIGNIFICANTLY FROM PRE-SURGERY TO POST-SURGERY (8.3±1.2 TO 2.9±0.7; P<(><<)>0.05), AS WAS THE ODI SCORE (76.4±12.5 TO 26.7±5.6; P<(><<)>0.05). THE SF-36 SCORES, INCLUDING BODILY PAIN (BF), VITALITY (VT), PHYSICAL FUNCTION (PF), AND SOCIAL FUNCTIONING (SF), ALL SHOWED NOTABLE IMPROVEMENT (P<(><<)>0.05). THESE VARIATIONS WERE MAINTAINED DURING THE 2-YEAR FOLLOW-UP PERIO D.HENCE, PKP IS A SAFE AND EFFECTIVE METHOD IN THE TREATMENT OF PAINFUL OOVFS. POST OPERATIVELY, CEMENT LEAKAGES WERE OBSERVED IN 12 (8.45%) TREATED VERTEBRAL BODIES. CEMENT EXTRAVASATION WAS LOCATED IN THE PARAVERTEBRAL SOFT TISSUES (6 LEAKS), VERTEBRAL VENOUS PLEXUS (2 LEAKS), AND ADJACENT DISK AREA (4 LEAKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556189 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR