BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM

    MDR report key: 11030699 · Received December 17, 2020

    Report

    Report Number
    1526439-2020-02432
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 20, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    UDI-DI
    10705034158877
    PMA / PMN Number
    K151885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: KWP AND NKG. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AND UNKNOWN PROCEDURE THAT THE PLATE BROKE PREMATURELY DURING BREAKING. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490119 MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION MNI MEDOS INTERNATIONAL SàRL CH 188362031 10705034158877

    Patients

    Seq Age Sex Outcome Treatment
    1