BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 8267876 · Received January 22, 2019

    Report

    Report Number
    1526439-2019-51262
    Event Type
    Injury
    Date Received
    January 22, 2019
    Report Date
    December 31, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: "IS THE POSTERIOR-ONLY APPROACH SUFFICIENT FOR TREATING CERVICAL SPINE METASTASES? THE EVIDENCE FROM A CASE SERIES." ENRICO GALLAZZI, LUCA CANNAVO`, GIUSEPPE G. PERRUCCHINI, ILARIA MORELLI, ALESSANDRO D. LUZZATI, CARMINE ZOCCALI, GENNARO SCOTTO. WORLD NEUROSURG. 2018 NOV 1. PII: S1878-8750 (18) 32445-8. DOI: 10.1016/J.WNEU.2018.10.147. RECEIVED 1 AUGUST 2018; ACCEPTED 22 OCTOBER 2018. N=1; POST OP SCREW LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59286 UNKNOWN SCREWS UNKNOWN KWP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention