BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5133981 · Received October 7, 2015

    Report

    Report Number
    1030489-2015-02587
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 9791223 AND 510K # K061274 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED . NO CONCLUSIONS CAN BE DRAWN . DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 6272415 / LOT: ZW40 PART: G9790025 / LOT: 0363697W PART: G9791223 / LOT: H5189773 PART: G9791223 / LOT: H5189773 PART: G9791223 / LOT: H5189773 ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION AT LEVELS C7-T1 ON AN UNKNOWN DATE. ON AN UNKNOWN DATE POST-OP, THE PATIENT'S PALSY GOT WORSENED. REVISION WAS SCHEDULED TO PERFORM POSTERIOR CERVICAL FIXATION. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662544 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H5189773

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention