BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7693058 · Received July 17, 2018

    Report

    Report Number
    1030489-2018-01003
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 2, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 7753500,510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY(CSM) AND UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY. DURING THE SURGERY, WHILE FINAL TIGHTENING THE MAS LOCKING SET SCREW, THE PROTRUSION PART OF THE MAS SET SCREW WAS BROKEN. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE SET SCREW WERE REMAINING IN THE PATIENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535213 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0562268W

    Patients

    Seq Age Sex Outcome Treatment
    1