BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6897711 · Received September 27, 2017

    Report

    Report Number
    1030489-2017-02122
    Event Type
    Injury
    Date Received
    September 27, 2017
    Report Date
    September 4, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    UDI-DI
    00613994667199
    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

    PART# G7755124 IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH PART# 7755124, 510(K): K082728 IS MARKETED IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. SUBMITTED POST-OP X-RAYS SHOWED ROD FRACTURE IN OCCIPITAL CERVICAL FUSION. THERE WERE MULTIPLE STRIPPED SEGMENTS IN THE CONSTRUCT WHICH WOULD HAVE PREDISPOSE THE CONSTRUCT TO FAILURE IF FUSION HAD NOT OCCURRED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION AT OC-C6. POST-OP, THE PATIENT COMPLAINED OF PAIN AT CERVICAL. PATIENT UNDERWENT X-RAY WHICH REVEALED BREAKAGE OF CONNECTOR PART OF THE ADJUSTABLE ROD AT OC-C2. THIS CAUSED PROTRUSION OF ROD AND PAIN. THE BROKEN ROD WAS SCHEDULED TO BE REMOVED ON (B)(6) 2017. NO INFORMATION REGARDING REVISION SURGERY WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677047 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK 00613994667199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention