BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SPINAL SYSTEM

    MDR report key: 1773873 · Received July 23, 2010

    Report

    Report Number
    1030489-2010-00955
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    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 # G7002526, 510K # K042524 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 CERVICAL SURGERY TO IMPLANT POSTERIOR FIXATION AT C4-C5. IT WAS REPORTED THAT THE SURGEON MISTAKENLY BROKE OFF THE CENTER NUT OF THE CROSSLINK. THE IMPLANT WAS REPLACED TO A NEW ONE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SPINAL SYSTEM CROSSLINK KWP WARSAW ORTHOPEDIC INC. NA 0000228W

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD:| IMPLANT DATE:| IMPLANT DATE:| SCREWS: