BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9390396 · Received November 28, 2019

    Report

    Report Number
    1030489-2019-01352
    Event Type
    Malfunction
    Date Received
    November 28, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 28, 2019
    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

    THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# G7752529; LOT#0432077W; QTY# 1. PART# G7752529; LOT#0730718W; QTY# 1. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 6950315, 510K# K052180 AND UPN (B)(4) IS APPROVED FOR MARKET IN THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION AT C2/7 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OPERATIVELY,THE LOCKING SET SCREWS COULD NOT BE PLACED. THE CROSSLINK PLACEMENT WAS STOPPED. THERE WAS A DELAY OF LESS THAN 60 MIN IN 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
    1184211 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0432077W

    Patients

    Seq Age Sex Outcome Treatment
    1