BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECKER RONGEUR CUP 2 X 6MM STR 6IN

    MDR report key: 5584843 · Received April 18, 2016

    Report

    Report Number
    1423507-2016-00053
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    February 8, 2016
    Report Date
    June 9, 2016
    Manufacturer
    WEBA MEDIZINTECHNIK GMBH & CO.
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER REQUESTED TO CLOSE THIS COMPLAINT AS IT WAS OPENED IN ERROR USING A PRODUCT THAT IS NOT FROM CAREFUSION/BD. IT WAS A COMPETITOR¿S PRODUCT AND MANUFACTURER (B)(4) WAS NOT INVOLVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON 3/29/2016, CUSTOMER ADVOCACY SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT NUMBER, AND INQUIRING IF ADDITIONAL INFORMATION MAY BE AVAILABLE. CONFIRMATION WAS ALSO REQUESTED FROM THE CUSTOMER THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH REPORTED ISSUE. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    USER STATED VIA MAUDE REPORT: MICRO PITUITARY RONGEUR PRONG CHIPPED DURING SURGICAL PROCEDURE ON PATIENT'S SPINE. SENDING SMALL METAL PIECE INTO SURGICAL FIELD. DIAGNOSIS OR REASON FOR USE: REMOVAL OF LOOSE BONE FRAGMENTS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. ON 12APR2016 ADDITIONAL INFORMATION: THE PROCEDURE THAT WAS BEING PERFORMED WAS A LUMBAR LAMINECTOMY. TIP NOTED ON X-RAY DURING PROCEDURE. TIP MAY HAVE BEEN SUCTIONED OUT DURING PROCEDURE. THERE WAS AN X-RAY PERFORMED DURING AND POST PROCEDURE. NO IMPACT ON PATIENT OUTCOME IMMEDIATELY POST PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. LOT NUMBER IS UNKNOWN. THIS IS A REUSABLE INSTRUMENT. SAMPLE IS UNAVAILABLE AS IT IS CURRENTLY WITH RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239300 DECKER RONGEUR CUP 2 X 6MM STR 6IN RONGEUR HTX WEBA MEDIZINTECHNIK GMBH & CO. NL6250 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other