BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9005768 · Received September 12, 2019

    Report

    Report Number
    1526439-2019-52065
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION 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

    A LITERATURE ARTICLE WAS REVIEWED: "TREATMENT OF THORACOLUMBAR BURST FRACTURES WITH VARIABLE SCREW PLACEMENT OR ISOLA INSTRUMENTATION AND ARTHRODESIS CASE SERIES AND LITERATURE REVIEW". GREGORY F. ALVINE, MD, JAMES M. SWAIN, MD, MARC A. ASHER, MD, AND DOUGLAS C. BURTON, MD. RECEIVED FOR PUBLICATION APRIL 14, 2003; ACCEPTED SEPTEMBER 4, 2003. N=7 ISOLA IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800776 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention