BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7532412 · Received May 22, 2018

    Report

    Report Number
    1030489-2018-00723
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 22, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THESE BELOW MENTIONED LOT NUMBERS OF THE PRODUCT WERE USED IN THE OPERATION. LOT# QUANTITY H5379631 1 H5379886 3 H5383087 2 H5385230 1 H5385605 4 THIS IS FOR NOTIFICATION PURPOSE AS THE LOT NUMBER OF THE ALLEGED PRODUCT COULD NOT BE SPECIFIED. 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 ON (B)(6) 2018, THE PATIENT UNDERWENT POSTERIOR CERVICOTHORACIC SPINE FUSION AT C2-T9. REPORTEDLY, WHEN SETTING THE SET SCREW DURING THE OPERATION, THE SET SCREW WAS FOUND TO BE THINLY PEELED OFF. THE SET SCREW WAS CROSS THREADED, BURR FROM THE SET SCREW PENETRATED THROUGH THE GLOVE AND PRICKED NURSE¿S FINGER. THEREFORE, THE NURSE PUT DOWN THE HAND AND RECEIVED TREATMENT FOR THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374897 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other