BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7908872 · Received September 26, 2018

    Report

    Report Number
    1030489-2018-01283
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 26, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7752526, 510K #K082728 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH AIS (ADOLESCENT IDIOPATHIC SCOLIOSIS)TYPE1 B AND UNDERWENT FIXATION SURGERY AT TH4- L1 LEVELS. POST-OPERATIVELY, MUSCLE WEAKNESS IN RIGHT LOWER LIMB WAS REPORTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750317 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0645435W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other