BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CURRETTE

    MDR report key: 2916397 · Received January 10, 2013

    Report

    Report Number
    MW5028586
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    October 17, 2012
    Report Date
    December 31, 2012
    Manufacturer
    LIFE INSTRUMENT
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS PT WITH SPINAL STENOSIS WITH NEUROGENIC CLAUDICATION L4-5 AND COMPRESSION FRACTURE L4-5 HAD A LAMINECTOMY OF L3, POSTEROLATERAL INSTRUMENTED SPINAL FUSION L3 TO L5, OPEN BIOPSY OF LEFT L4 PEDICLE, USE OF CALCIUM PHOSPHATE OSTEOCONDUCTIVE MATERIAL, USE OF MORSELLIZED ALLOGRAFT BONE AND A PARTIAL L5 LAMINECTOMY WAS ALSO PERFORMED. WHILE HIS FRACTURE WAS BENIGN IN APPEARANCE, IT WAS DEEMED APPROPRIATE TO PERFORM A BIOPSY OF THE VERTEBRAL BODY AS WELL AS THE LEFT L4 PEDICLE TO ENSURE THAT THERE WAS NO PATHOLOGIC NATURE OF THIS FRACTURE. THIS WAS DONE BY DECORTICATING THE CONFLUENCE OF THE TRANSVERSE PROCESS LATERAL JOINT SURFACE AND PARS INTERARTICULARIS ON THE LEFT HAND SIDE. THE PEDICLE WAS THEN BREACHED USING A BLUNT PEDICLE FINDER. A SMALL CURETTE WAS THEN USED TO GENTLY REMOVE CANCELLOUS BONE FROM THE VERTEBRAL BODY AS WELL AS THE PEDICLE. WHILE THIS WAS BEING DONE, THE TIP OF A SMALL ANGLED CURET BROKE OFF. ATTEMPTS WERE MADE TO REMOVE THIS. THIS WAS NOT POSSIBLE. C-ARM MAGNIFICATION CONFIRMED APPROPRIATE LOCATION OF THIS TIP IN THE VERTEBRAL BODY. IT WAS FELT THAT REMOVING THIS WOULD CAUSE UNDUE HARM TO BOTH THE BONY STRUCTURES AND POSSIBLE NEURAL ELEMENTS. GIVEN THAT THE INSTRUMENT WAS CLEAN AND IMBEDDED IN THE VERTEBRAL BODY, IT WAS ALSO FELT THAT NO UNDUE RISK WOULD BE POSED BY LEAVING THIS PIECE OF HARDWARE IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14946 SMALL CURRETTE SMALL CURRETTE FZS LIFE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other