BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RODS

    MDR report key: 7646159 · Received June 28, 2018

    Report

    Report Number
    1526439-2018-50606
    Event Type
    Injury
    Date Received
    June 28, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MDM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS GENERATED FROM LITERATURE REVIEW CONDUCTED IN POST MARKET SURVEILLANCE (PMS) FOR HEALTH AUTHORITY REPORTING PURPOSES. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE PMS IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: RIGID OCCIPITOCERVICAL FIXATION: INDICATIONS, OUTCOMES AND COMPLICATIONS OF THE MODERN ERA. (B)(4). N=1 BROKEN ROD AND 1 LOOSE SCREW. N=1 TWO SCREW PULL OUT. N=1 TWO BROKEN RODS AND 1 LOOSE SCREW. N=1 BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488171 UNKNOWN RODS UNKNOWN MDM MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other