BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 6449002 · Received March 31, 2017

    Report

    Report Number
    1030489-2017-00716
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 7, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# LOT# 510K# UDI# QTY 7650091 UNK EXEMPT NA 2 7570900 UNK K052747 (B)(4) 1 815-517 UNK EXEMPT NA (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    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 DURING SURGERY, THE DEVICES WERE NOT WORKING PROPERLY. SCREW RETAINING DRIVER COULD NOT HOLD THE SET SCREWS BEFORE AND AFTER FINAL TIGHTENING. ROD HOLDER WAS ALSO DAMAGED AND COULD NOT WORK ANYMORE. THE TIP OF THE DRIVER WAS DAMAGED DUE TO CONTINUOUS USE. DUE TO ABOVE ISSUES WITH PRODUCTS, THE SURGICAL PROCEDURE WAS CHANGED FROM MINIMALLY INVASIVE SURGERY TO OPEN SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230958 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other