BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1161466 · Received September 11, 2008

    Report

    Report Number
    1030489-2008-00507
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    WARSAW ORTHOPEDICS INC.
    Product Code
    JDN
    PMA / PMN Number
    K042922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE. ONE MONTH LATERAL POST-OP X-RAY SHOWS THAT CERVICAL SPINE WITH PLATE PRESENTS C2 TO C5. ONE OF C5 SCREWS HAS BACKED OUT SEVERAL MILLIMETERS. NO CLEAR CORPECTOMY GRAFT CAN BE SEEN. PREVIOUS FUSION C5 TO C7 APPEARS SOLID. 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 PATIENT UNDERWENT A C3 CORPECTOMY USING ANTERIOR CERVICAL PLATE AT C2-C4. APPROXIMATELY 1 MONTH POST-OP, THE C4 SCREWS REPORTEDLY BACKED OUT OF THE PLATE. NO REVISION SURGERY IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM PLATE JDN WARSAW ORTHOPEDICS INC. NA W08D1652

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR