BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7271009 · Received February 14, 2018

    Report

    Report Number
    1030489-2018-00218
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 14, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 7752500, 510K#K062879 AND UPN (B)(4) IS AVAILABLE FOR THE MARKET. THE DEVICE WAS NOT 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 THE PATIENT UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION AT C3-C7 DUE TO CERVICAL SPINAL STENOSIS. INT RA-OP, WHEN ATTEMPTING TO TORQUE OFF THE MULTIAXIAL SCREW (MAS) CROSSLINK LOCKING SCREW THE HEX TOP OF THE MAS CONNECTOR SET SCREW SHEARED OFF, MAKING ATTACHMENT OF A CROSSLINK IMPOSSIBLE AND REMOVAL OF THE BROKEN CONNECTOR SCREW IMPOSSIBLE WITHOUT REMOVING THE CONSTRUCT COMPLETELY. THE SURGON, DID NOT WANT TO REMOVE THE CONSTRUCT AND DECIDED, SINCE THE CONNECTOR SET SCREW HAD BEEN TORQUE OFF, TO LEAVE IT IN PLACE WITHOUT A CROSSLINK. THE THREADED PART OF THE SET SCREW TORQUED OFF INSIDE THE HEAD OF THE MULTIAXIAL SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113428 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1