BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1062930 · Received June 19, 2008

    Report

    Report Number
    1030489-2008-00279
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    HRS
    PMA / PMN Number
    K042922
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IMPLANTS WERE RETURNED TO MFR FOR EVAL. THE EXPLANTED PLATE AND LOCKING MECHANISM APPEAR TO BE TO SPECIFICATION AND STILL FUNCTIONAL. ALL BONE SCREWS APPEAR TO BE TO SPECIFICATION. WITHOUT X-RAYS TO ASCERTAIN POST OP BONE SCREW ANGULATION AND POSITION WITH RESPECT TO LOCK, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE USING ANTERIOR FIXATION. ONE OF THE CAUDAL SCREWS OF THE PLATE REPORTEDLY BACKED OUT 3MM THREE MONTHS POST OP. THE PT BEGAN TO HAVE INCREASING SORENESS. THE PT REPORTEDLY HAD NO SIGN OF IMPLANT LEVEL SUBSIDENCE. THE REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT APPROX. 7 MONTHS POST OP. AT THE REVISION SURGERY, IT WAS FOUND THAT THE SCREW BACKED OUT 10MM. IT WAS ALSO FOUND AT THE REVISION SURGERY THAT THE BOTTOM LOCKING MECHANISM HAD NOT CAPTURED THE FLANGES OF EITHER OF THE BOTTOM SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM PLATE HRS WARSAW ORTHOPEDIC INC. NA M07F1276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention