BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1550294 · Received December 2, 2009

    Report

    Report Number
    2953769-2009-00184
    Event Type
    Injury
    Date Received
    December 2, 2009
    Date of Event
    January 1, 2009
    Report Date
    November 9, 2009
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE. EUR SPINE J (2009) 18:1713-1826, PAGE 1771 - P 72 - ABSTRACT TITLED "INTRADURAL PMMA LEAKAGE AND INCOMPLETE CONUS SYNDROME AFTER PERCUTANEOUS KYPHOPLASTY WITHOUT DURAL LESION: CASE REPORT" BY G. BRINKER, M. REINER, W. VON TEMPELHOFF, R.-I. ERNESTUS, R. GOLDBRUNNER. DEVICE NOT RETURNED, FOLLOW UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "INTRADURAL PMMA LEAKAGE AND INCOMPLETE CONUS SYNDROME AFTER PERCUTANEOUS KYPHOPLASTY WITHOUT DURAL LESION: CASE REPORT", THE FOLLOWING EVENT WAS REPORTED: "A FEMALE SUFFERING FROM A FRACTURE OF THE 12TH THORACAL VERTEBRA WAS TREATED BY PERCUTANEOUS TRANSPEDICULAR KYPHOPLASTY WITH PMMA. POSTOPERATIVELY, AN EPIDURAL HEMATOMA WAS EVACUATED. DURING THE FOLLOWING MONTHS, THE PATIENT PRESENTED A PROGREDIENT CONUS/CAUDA EQUINA SYNDROME. MYELOGRAPHIC CT AND MRI SHOWED AN INTRADURAL SPACE OCCUPYING LESION NEXT TO THE CONUS, WHICH WAS ACCORDING TO ITS SIGNAL INTENSITY SUSPECTED TO BE PMMA. SURGERY WAS PERFORMED BY HEMILAMINECTOMY OF T-12 AND INTRADURAL DECOMPRESSION OF THE CONUS/CAUDA. AN INTRADURAL PMMA-MASS (15X5X4 MM) NEXT TO THE CONUS WAS REMOVED. BASED ON EVIDENCE, IT IS ASSUMED THAT THE PMMA LEAKAGE WAS DUE TO TRANSVENOUS INFLOW VIA EPIDURAL-INTRADURAL ANASTOMOSIS. THREE MONTHS POSTOPERATIVELY THE CLINICAL STATE IMPROVED MARKEDLY, BUT INCOMPLETELY." NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R