BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1604042 · Received February 11, 2010

    Report

    Report Number
    1030489-2010-00167
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 12, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE PART OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE FOR CATALOG# 9790313 AND 9790311, 510K# K042922 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF AT C3-C6 USING ANTERIOR CERVICAL PLATE AND SCREWS. IT WAS REPORTED THAT THE SCREW WAS NOT INSERTED DEEP ENOUGH AT RIGHT C3. THEREFORE, THE LOCKING RING WOULD NOT BE PLACED. IN ORDER TO IMPLANT THE LOCKING RING, THE SCREW WAS NOT IMPLANTED AT RIGHT SIDE C3. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR SELF-TAPPING VARIABLE SCREW: CATALOG# G9790311| IMPLANT DATE:| G9790311| ANTERIOR CERVICAL PLATE| IMPLANT DATE: