BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6669144 · Received June 27, 2017

    Report

    Report Number
    1030489-2017-01626
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    May 31, 2017
    Report Date
    August 15, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958716, 510K # K081297 AND UPN (B)(4) WAS CLEARED IN THE UNITED STATES. REVISION SURGERY. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE COMPLETE AND SYMMETRICAL WITNESS MARKS ON THE CROWN OF THE MAS SUGGEST FULL SEATING ROD AND TIGHTENING OF THE SCREW. VISUAL AND FUNCTIONAL REVIEW OF THE IMPLANT SUGGESTS THE IMPLANT IS CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: FRACTURE DISLOCATIONS(C6-C7) PROCEDURE:PSF (POSTERIOR SPINAL FUSION) LEVELS: C6/C7 IT WAS REPORTED THAT POST-OP, IMPLANTED SCREW DEVIATED AND A REVISION SURGERY WAS DONE FOR REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450551 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5212293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention