BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPREP BOX CURETTE

    MDR report key: 1971996 · Received January 13, 2011

    Report

    Report Number
    1971996
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES, INC.
    Product Code
    HTF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT WAS UNDERGOING POSTERIOR LUMBAR LAMINECTOMY OF THE BILATERAL LUMBAR VERTEBRA (L5) AND SACRAL VERTEBRA (S1). PATIENT ALSO UNDERWENT PLACEMENT OF ANTERIOR LUMBAR INTERVERTEBRAL DEVICE (L5-S1), ANTERIOR SPINAL ARTHRODESIS (L5-S1), POSTERIOR SPINAL ARTHRODESIS (L5-S1), PLACEMENT OF POSTERIOR SPINAL INSTRUMETATION (L5-S1), BONE MARROW ASPIRATION, HARVEST OF FAT GRAFT AND PLACEMENT OF FAT GRAFT OVER THE DURA, AND REPAIR OF A DURAL DEFECT. PHYSICIAN WAS USING A SYNTHES BOX CURETTE DURING PROCEDURE. THE TIP OF THE SYNTHES BOX CURETTE BROKE. THE TIP OF THE SYNTHES BOX CURETTE WAS REMOVED FROM THE SURGICAL SITE. DEVICE WAS SUBSTITUTED WITH A NEW SYNTHES BOX CURETTE, AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO UNTOWARD EFFECTS FROM BROKEN SYNTHES BOX CURETTE. THE BROKEN SYNTHES BOX CURETTE AND TIP WERE WASHED AND BAGGED AND GIVEN TO THE SYNTHES REPRESENTATIVE. REPRESENTATIVES ARE TO HAVE SYNTHES EXAMINE BROKEN SYNTHES BOX CURETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPREP BOX CURETTE CURETTE HTF SYNTHES, INC. 03.605.003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR