BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1698065 · Received May 21, 2010

    Report

    Report Number
    1030489-2010-00674
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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 # 6955408, 510K # K003780 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE POST-OP FILMS WERE REVIEWED. THEY SHOW COMPLEX CONSTRUCT OCCIPITAL TO CERVICAL AND CERVICAL SCREWS STRIPPING OUT OF BONE ALLOWING SKULL AND UPPER CERVICAL SPINE TO FLEX AWAY FROM IMPLANTED PLATE. PICTURES OF COMPLAINT PRODUCT SUBMITTED FOR ANALYSIS; PLATE AND SCREW DOES NOT APPEAR TO REVEAL ANY MATERIAL OR FUNCTIONAL DEFECT. UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE SUBMITTED PICTURES. 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 POSTERIOR FUSION PROCEDURE AT OCCIPUT TO C7 TO IMPLANT POSTERIOR FIXATION PLATE, RODS AND SCREWS. REPORTEDLY, THE FUSION PROCEDURE WAS COMPLETED PROPERLY. THE CONSTRUCT REPORTEDLY HAD NO PROBLEMS IMMEDIATE POST OP. THE X-RAYS TAKEN TWO WEEKS POST OP SHOWED THAT THE MIDLINE PLATE BACKED OUT AS WELL AS THE TWO LOWER SCREWS, BUT THE UPPER SCREW REMAINED IN UNION. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY A MONTH POST FUSION PROCEDURE. THE IMPLANTS AT OCCIPUT WERE ALL REMOVED BY CUTTING OFF THE ROD AT THE TRANSITION SITE OF THE OCCIPUT AND CERVICAL. THE REST OF THE CERVICAL CONSTRUCT WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM CORITCAL SCREW KWP MEDTRONIC SOFAMOR DANEK NA H09F8768

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANTED:| PLATE:| IMPLANTED:| EXPLANTED:| SET SCREWS:| RODS:| EXPLANTED:| EXPLANTED:| IMPLANTED: