BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX® RECONSTRUCTION SYSTEM

    MDR report key: 6796520 · Received August 16, 2017

    Report

    Report Number
    1030489-2017-01913
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    July 19, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    REFER 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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 7753806 AND 510K# K123656 AND (B)(4) IS APPROVED FOR SALE IN THE US. 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

    ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL KYPHOSIS USING TAPERED ROD. REPORTEDLY, ON AN UNKNOWN DATE, POST-OP, ROD BREAKAGE WAS OBSERVED AT LEFT OF O-C2. THE PATIENT ALSO HAD POOR ALIGNMENT AND EXPERIENCED RECURRENCE OF NUMBNESS IN HANDS. THE PATIENT HAD NOT ACHIEVED BONE FUSION. ON (B)(6) 2017, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT O-T3. THE BROKEN RODS WERE REMOVED AND FOUR RODS FIXATION WAS CONSTRUCTED. NO FRAGMENTS OF THE IMPLANTS REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577375 VERTEX® RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention