BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 9150668 · Received October 3, 2019

    Report

    Report Number
    1030489-2019-01111
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE 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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9790077, 510K # K042922, UDI# (B)(4). 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 HAD TO UNDERWENT REVISION SURGERY DUE TO THE FORMATION OF ABSCESS AT C3-C7. POST-OP, DURING A FOLLOW UP ABSCESS APPEARED ON THE ANTERIOR SIDE OF THE PLATE AND VOCAL CHORDS WERE COMPRESSED ON A PATIENT WHO UNDERWENT ANTERIOR CERVICAL FIXATION. THE AIRWAY HAD BEEN PRESSED AND IT WAS DIFFICULT FOR THE PATIENT TO BREATHE, AND THE PATIENT COULD NOT SAY ANYTHING. HOWEVER, DURING THE REVISION SURGERY NO ABSCESS WAS FOUND EVEN AS THE PROCEDURE WAS PROCEEDED, FINALLY, WASHING WAS PERFORMED, AND WOUND WAS CLOSED WITHOUT REMOVING THE PLATE. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945836 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0595058W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other