BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCSS SCREW SET

    MDR report key: 9989736 · Received April 23, 2020

    Report

    Report Number
    1030489-2020-00471
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 23, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 873-136, 510K #: K003928 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. X-RAY REVIEW RESULTS: A POST-OP IMAGE FOR AN ODONTOID SCREW/C2 FIXATION IS PROVIDED. THE BOTTOM OF THE SCREW EXTENDS OUT OF THE C2 BODY A LITTLE BIT AND IMAGE QUALITY MAKES IT DIFFICULT TO SEE THE APPOSITION OF THE DENS TO VERTEBRAL BODY. BY REPORT, THE SURGICAL TECHNIQUE WAS INCORRECT, NO HARDWARE FAILURE WAS IDENTIFIED. 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 PRESENTED WITH ODONTOID PROCESS FRACTURE; AND UNDERWENT A SURGERY AT C2 USING NAKANISHI METHOD. INTRA-OP, IN ORDER TO DETERMINE THE SCREW LENGTH, WHEN AN ATTEMPT WAS MADE TO MEASURE WITH A DEPTH GAUGE, IT WAS NOTICED THAT THE ENGRAVED POSITION OF THE GUIDE WIRE WAS WRONG. THIS REVEALED THAT THE GUIDE WIRE WAS INSERTED IN THE OPPOSITE DIRECTION. THE DIRECTION OF INSERTING GUIDE WIRE WAS WRONG, AND THE BLUNT SIDE WITHOUT THE THREAD WAS INSERTED TO THE VERTEBRA BODY. THE SURGEON MANAGED TO DETERMINE THE SCREW LENGTH WITH THE GUIDE WIRE AS IT WAS AND THE SCREW WAS PLACED. HOWEVER, SCREW INSERTION WAS NOT AT THE POSITION THAT THE SURGEON EXPECTED. MOREOVER, BONE FRAGMENT WAS PUSHED BY WRONG USE OF THE SURGEON, AND THE FRACTURE LINE DEVIATED. ALTHOUGH NO PATIENT COMPLICATIONS WERE REPORTED, THERE IS A POSSIBILITY OF CONSIDERING A RE-OPERATION DUE TO THE IMPERFECTION OF REDUCTION. THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453404 UCSS SCREW SET KWP WARSAW ORTHOPEDICS NA 0640075W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention