BEUDAMED
    FDA Adverse Event Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2184462 · Received July 29, 2011

    Report

    Report Number
    1030489-2011-00974
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(6). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6955934, 510K # K042789 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO EXTEND THE FUSION ON LEVEL. DURING THE PROCEDURE, ALL PREVIOUS IMPLANTED DEVICES WERE EXPLANTED EXCEPT A TIP OF BROKEN SCREW AT RIGHT C7. THE NEW IMPLANT CONSTRUCT WAS IMPLANTED AT C2/T5. THE TOP OF THE BROKEN SCREW IS REMAINED IN THE PATIENT. NO OTHER COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA PU93

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR RODS, SET SCREWS