BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2356603 · Received December 2, 2011

    Report

    Report Number
    1030489-2011-01556
    Event Type
    Malfunction
    Date Received
    December 2, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PART OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE PARTS THAT WERE USED ARE PART# 9791323 AND 9795325. THE 510K FOR 9791323 IS K061274; 510K FOR 9795325 IS K042922. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C4-7. IT WAS REPORTED THAT A SCREW WAS FOUND TO HAVE BACKED OUT ON X-RAY. NO PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY HAS BEEN SCHEDULED AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE