BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1637121 · Received March 19, 2010

    Report

    Report Number
    1030489-2010-00288
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 23, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6950305, 510K # K042498 WAS CLEARED IN THE UNITED STATED. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WAS RETURNED TO THE MFR FOR EVAL. 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 SPECS. THE PT UNDERWENT A REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT INITIALLY UNDERWENT A PROCEDURE TO FUSE C2-7 USING POSTERIOR FIXATION AND CABLE AT C2-C7 AND C3-C6. IT WAS FOUND THAT THE SET SCREW WAS LOOSENING AT LEFT C2; THEREFORE, THE ROD WAS OFF FROM THE PEDICLE SCREW POST OP. THE REVISION SURGERY WAS PERFORMED APPROX 9 DAYS POST OP. AT THE REVISION SURGERY, C2 SET SCREW WAS REPLACED. THE ROD WAS BENT TO RE-APPLY TO LEFT C2. THE THIRD CROSSLINK WAS ADDED AT THE REVISION SURGERY. THE SURGEON STATED THAT THE ROD CAME OFF BECAUSE THE ROD AND THE SCREWS MAY NOT HAVE IMPLANTED ORTHOGONALLY AGAINST EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM SET SCREW KWP WARSAW ORTHOPEDIC INC. NA 0063705W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD: IMPLANT:| PEDICLE SCREW: IMPLANT: