BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3891189 · Received June 24, 2014

    Report

    Report Number
    1030489-2014-02861
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUAL AND OPTICAL EXAMINATION OF ALL OF THE RETURNED BONE SCREWS DID NOT IDENTIFY LOCKING CAP WITNESS MARKS ON THE HEAD OF ONE OF THE SCREWS. ADDITIONALLY, ATYPICALLY LIGHT WITNESS MARKS NOTED ON THE EDGE OF BONE SCREW LOCK WASHER INTERFACING SURFACE, CONSISTENT WITH MINIMAL LOCK WASHER INTERFACE. WITNESS MARKS NOTED AT THE UPPER OUTSIDE AND LOWER INSIDE PORTION OF ONE OF PLATE SCREW HOLES, SUGGESTING THE SCREW MAY HAVE BEEN INSERTED OFF-AXIS, WHICH CAN REDUCE THE MECHANICAL ENGAGEMENT BETWEEN THE BONE SCREW HEAD, AND THE LOCK WASHER. X-RAY INTERPRETATION: "THIS SHOWS X-RAYS OF AN ACDF AT C5/6. INITIAL POSTOP FILMS, AND CT SHOW THE SCREWS TO BE WELL POSITIONED IN RELATION TO THE PLATE. A LATER FILM SHOWS SOME SUBSIDENCE OF THE GRAFT BUT CLEAR BACK OUT OF ONE OF THE C6 SCREWS AND FAILURE OF THE LOCKING MECHANISM TO CONTROL THE SCREW."

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G9790027 / LOT: 0251835W PART: G9791223 / LOT: H13E3594 (X4). ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACDF AT C5-C6 AND SOMETIME POST-OPERATIVELY, SCREW DISPLACEMENT OCCURRED AT C6. A REVISION SURGERY WAS PERFORMED BECAUSE THE STABILITY OF THE CONSTRUCT WAS REPORTEDLY REDUCED. AS BONE UNION WAS ALSO NOT ACHIEVED, AN S-PLATE WAS ADDED POSTERIORLY AND THE ANTERIOR PLATE WAS REPLACED WITH THE LARGER ONE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE SCREW DISPLACEMENT WAS UNKNOWN BECAUSE THE SCREWS WERE PROPERLY LOCKED DURING IMPLANTATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368234 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13E3594

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention 27.5MM PLATE, 4.0X13MM SELF DRILL FIX SCREW (X3)