BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREW, 3.5 MM SELF DRILLING/TAPPING

    MDR report key: 4223511 · Received October 29, 2014

    Report

    Report Number
    1833824-2014-00022
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 2, 2011
    Report Date
    October 29, 2014
    Manufacturer
    PIONEER SURGICAL
    Product Code
    OUR
    PMA / PMN Number
    K102903
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVOLVED WAS NOT RETURNED TO PIONEER SURGICAL FOR EVAL. SINCE THE DEVICE WAS NOT RETURNED THE LOT NUMBER FOR THIS SCREW IS UNK. A REVIEW OF THE DHR COULD NOT BE COMPLETED. SINCE THERE IS NO MORE INFO ABOUT THIS OCCURRENCE PIONEER SURGICAL IS LIMITED IN OUR INVESTIGATION. IF FURTHER INFO BECOMES AVAILABLE PIONEER SURGICAL WILL SEND A FOLLOW UP RESPONSE TO THE FDA.

    Description of Event or Problem · 1

    THE PT EXPERIENCED NECK PAIN AFTER A TRANSARTICULAR SCREW BROKE, WHICH WAS IMPLANTED IN THE CERVICAL SPINE (C1-C2) APPROX A YEAR PRIOR. ON (B)(6) 2011 THE BROKEN SCREW WAS REMOVED AND THE PT WAS REVISED WITH AN OCCIPITOCERVICAL FUSION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692771 CANNULATED SCREW, 3.5 MM SELF DRILLING/TAPPING OUR PIONEER SURGICAL 00-1147-XX-36 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention