BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4598820 · Received March 13, 2015

    Report

    Report Number
    1030489-2015-00542
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE PARTS USED IN THE PROCEDURE WERE: PART # 6958718, LOT # H10M3459; PART # 6958720, LOT # H13F1718, LOT # H13G0809, LOT # H13G1815; LOT # 6950315, LOT # H13F0298; PART # 6900240, LOT # 0269976W. (B)(4). MANUFACTURE DATE FOR PART # 6958718, LOT H10M3459 IS (B)(4) 2010; MANUFACTURE DATE FOR PART # 6958720, LOT H13F1718 IS (B)(4) 2013; LOT H13G0809 IS (B)(4) 2013; LOT H13G1815 IS (B)(4) 2013; MANUFACTURE DATE FOR PART # 6950315, LOT H13F0298 IS (B)(4) 2013; MANUFACTURE DATE FOR PART # 6900240, LOT 0269976W IS (B)(4) 2013. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE TO TREAT A CERVICAL VERTEBRAE FRACTURE. SOMETIME POST-OP IT WAS FOUND THAT THE ¿PRODUCTS HAD FALLEN OFF.¿ THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE CONSTRUCT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173611 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention