BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTENE

    MDR report key: 2465187 · Received February 21, 2012

    Report

    Report Number
    3004961344-2012-00001
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 20, 2012
    Manufacturer
    CEREMED
    Product Code
    MTJ
    PMA / PMN Number
    K050440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WHO PERFORMED THE SURGERY CONCLUDED THAT OSTENE WAS NOT THE CAUSE OF THE EPIDURAL HEMATOMA AND THEREFORE, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION AS THERE IS NO EVIDENCE AT THIS TIME THAT OSTENE WAS THE CAUSE OF THE EPIDURAL HEMATOMA.

    Description of Event or Problem · 1

    OSTENE 2.5G USED DURING LUMBAR DECOMPRESSION SURGERY. ISSUES CAM UP CAUSING SECOND SURGERY (EPIDURAL HEMATOMA). SCRUB TECH THOUGHT IT MIGHT HAVE BEEN CAUSED BY OSTENE, BUT SURGEON THOUGHT EPIDURAL HEMATOMA WAS NOT CAUSED BY OSTENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTENE OSTENE MTJ CEREMED BW-012 5267

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other