BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX® RECONSTRUCTION SYSTEM

    MDR report key: 6375383 · Received March 3, 2017

    Report

    Report Number
    1030489-2017-00451
    Event Type
    Injury
    Date Received
    March 3, 2017
    Report Date
    February 6, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    REFER H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 7753745 AND 510K# K123656 AND (B)(4) IS APPROVED FOR SALE IN THE US. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT POSTERIOR FUSION AT LEVELS C1-2 DUE TO PRE-OP DIAGNOSIS: ATLANTOAXIAL SUBLUXATION. REPORTEDLY, POST-OP, ON AN UNKNOWN DATE, THE TIP OF THE ROD ON THE C1 INTERFERED WITH THE OCCIPITAL BONE. IT¿S UNKNOWN WHETHER IT OCCURRED IN RETROFLEXION OR DUE TO LOOSENING OF THE SET SCREW. PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT HAS BEEN REPORTED UNKNOWN. RE-OPERATION WAS SCHEDULED ON (B)(6). THE C3 SCREW WILL BE ADDED AND THE RODS POSITION WILL BE PLACED LOWER OR REPLACED TO PREVENT CONTACT WITH OCCIPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159511 VERTEX® RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0395362W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention