BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR PLATE FLUSH H.12

    MDR report key: 4861531 · Received June 19, 2015

    Report

    Report Number
    3005180920-2015-00125
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 20, 2015
    Report Date
    September 24, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    PMA / PMN Number
    K124034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6/19/2015: LOT 140603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/14/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 125088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6/10/2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 6/09/2015 IT WAS COMMUNICATED THAT THE ITEM WAS NOT AVAILABLE, BUT THE SALES WAS GOING TO VERIFY IT AGAIN.

    Additional Manufacturer Narrative · 1

    ON 28 AUGUST 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 31 AUGUST 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398949 MECTALIF ANTERIOR PLATE FLUSH H.12 SPINAL PLATE FOR ANTERIOR CAGE OVD MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other