BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1569853 · Received December 31, 2009

    Report

    Report Number
    1030489-2009-01259
    Event Type
    Injury
    Date Received
    December 31, 2009
    Report Date
    December 4, 2009
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #6955240, 510K # K003780 WAS CLEARED IN THE UNITED STATES. ONE POST OP X-RAY WAS RECEIVED BY THE MFR. COMPLEX CONSTRUCT FROM OCCIPUT TO T2 SHOWS BILATERAL POSTERIOR ROD AND SCREWS. THE ROD FRACTURED AT AS ABOUT C2 LEVEL. 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 SPINAL PROCEDURE TO FUSE O/T2. POSTERIOR FIXATION ROD WAS IMPLANTED. ONE ROD WAS FOUND BROKEN AT UNK TIME POST OP. THE OTHER ROD ALSO WAS BROKEN JUST BEFORE THE REVISION SURGERY. THE REVISION SURGERY WAS PERFORMED APPROX THREE MONTHS POST THE RODS WERE IMPLANTED. AT THE REVISION SURGERY, IT WAS CONFIRMED THAT FUSION OCCURRED AT THE TREATED LEVELS BUT OSTEOLYSIS WAS OBSERVED AT RIGHT C1. THE SURGEON SUSPECTED THAT THE 3.2 MM ROD MAY NOT BE TOLERABLE FOR THE PT'S INVOLUNTARY MOVEMENT ASSOCIATED WITH CEREBRAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM ROD KWP WARSAW ORTHOPEDIC INC. NA 0014528W

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention