BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12074143 · Received June 28, 2021

    Report

    Report Number
    1030489-2021-00849
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    November 6, 2020
    Report Date
    June 28, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    YONGCHAO LI., XIAOFEI FENG., JIE PAN., MINGJIE YANG., LIJUN LI., QIHANG SU., JUN TAN. PERCUTANEOUS VERTEBROPLASTY VERSUS KYPHOPLASTY FOR THORACOLUMBAR OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES IN PATIENTS WITH DISTANT LUMBOSACRAL PAIN. PAIN PHYSICIAN. 24:E349-E356 (2020) " ISSN 2150-1149. OBJECTIVES: TO COMPARE THE CLINICAL EFFICACY AND IMAGING OUTCOMES OF PERCUTANEOUS VERTEBROPLASTY (PVP) AND PERCUTANEOUS KYPHOPLASTY (PKP) IN THE TREATMENT OF DISTANT LUMBOSACRAL PAIN ACCOMPANIED BY THORACOLUMBAR OVCF AND TO EXPLORE THE POSSIBLE PATHOGENESIS OF DISTANT LUMBOSACRAL PAIN CAUSED BY THORACOLUMBAR OVCF. METHODS: A TOTAL OF 62 PATIENTS WHO UNDERWENT VERTEBRAL AUGMENTATION FOR THORACOLUMBAR OVCF WITH LUMBOSACRAL PAIN WERE INCLUDED AND DIVIDED INTO THE PVP GROUP (28 CASES) AND THE PKP GROUP (34 CASES). THE VISUAL ANALOG SCALE (VAS) WAS USED TO EVALUATE THE SEVERITY OF LOCAL AND DISTANT LUMBOSACRAL PAIN, AND THE CHINESE MODIFIED OSWESTRY DISABILITY INDEX (CMODI) WAS USED FOR FUNCTIONAL ASSESSMENT. THE ANTERIOR VERTEBRAL HEIGHT (AVH) OF THE FRACTURED VERTEBRAE AND LOCAL KYPHOTIC ANGLE WERE MEASURED ON PLAIN RADIOGRAPHS. THE AVERAGE FOLLOW-UP TIME WAS 28.62 ¿ 8.43 MONTHSIN THE PVP GROUP AND 29.22 ¿ 9.09 MONTHS IN THE PKP GROUP. REPORTED EVENT: THE OPERATION TIME WAS SIGNIFICANTLY LONGER IN THE PKP GROUP (35.79 ¿ 3.26 MIN) THAN IN THE PVP GROUP (30.82 ¿ 2.79 MIN) (P = 0.000). ELEVEN PATIENTS (17.7%) HAD BONE CEMENT LEAKAGE, INCLUDING 7 PATIENTS (25.0%) IN THE PVP GROUP AND 4 PATIENTS (11.8%) IN THE PKP GROUP. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P = 0.175). THE MEAN FOLLOW-UP DURATION WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE 2 GROUPS (28.62 ¿ 8.43 MONTHS IN THE PVP GROUP VS. 29.22 ¿ 9.09 MONTHS IN THE PKP GROUP, P = 0.678). DURING THE FOLLOW-UP PERIOD, THERE WERE 7 CASES (12.1%) OF SECONDARY VERTEBRAL FRACTURES, INCLUDING 3 CASES (11.5%) IN THE PVP GROUP AND 4 CASES (12.5%) IN THE PKP GROUP. SYMPTOMS IMPROVED AFTER VERTEBRAL AUGMENTATION WAS PERFORMED A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978515 UNKNOWN MQP MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1