BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILD

    MDR report key: 1997914 · Received February 11, 2011

    Report

    Report Number
    3006450448-2011-00001
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 10, 2011
    Manufacturer
    VERTOS MEDICAL
    Product Code
    NBH
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS FEMALE, PT, APPROX (B)(6), PRESENTED FOR TREATMENT WITH HISTORY OF ARACHNOIDITIS AND ADHESIONS WHICH ARE BOTH THOUGHT BY THE SURGEON TO HAVE CONTRIBUTED TO THIS EVENT. DURING LAMINOTOMY AND TISSUE RESECTION TO DECOMPRESS THE LUMBAR SPINE AT L3-4, A DURAL TEAR OCCURRED. THIS EVENT OCCURRED WHILE PERFORMING THE PROCEDURE WITHOUT THE REQUIRED EPIDUROGRAM. DURING USE OF THE RONGEUR AT THE END OF THE CASE, THE DURA WAS TORN AND A SMALL AMOUNT OF CSF WAS OBSERVED COMING OUT OF THE TROCAR. THE TROCAR WAS REMOVED, THE WOUND SUTURED, AND PT RECOVERED AND WAS DISCHARGED TO RETURN HOME. PT CALLED THE NEXT DAY ((B)(6) 2011) COMPLAINING OF HEADACHE AND VOMITING, BUT CONTINUED TO EAT AND DRINK FLUIDS. DAY 3 ((B)(6) 2011) AFTER THE PROCEDURE, THE PT PRESENTED WITH PERSISTENT HEAD ACHE AND SOME VOMITING AND WAS TREATED USING A 20CC BLOOD PATCH. FOLLOWING TREATMENT THE PT WAS OBSERVED, REPORTED FEELING BETTER AND SUBSEQUENTLY RETURNED HOME. THE EVENING OF THE 4TH POSTOPERATIVE DAY ((B)(6) 2011) THE PT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF HEADACHE AND WAS SCHEDULED FOR LAMINECTOMY AND DURAL REPAIR. NO REPORT OF THAT PROCEDURE HAS BEEN REC'D AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILD BONE RONGEUR NBH VERTOS MEDICAL MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization