BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM

    MDR report key: 7380661 · Received March 29, 2018

    Report

    Report Number
    3005180920-2018-00192
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030833557
    PMA / PMN Number
    K124034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 23 MARCH 2018; INFECTION OCCURRED 3 MONTHS AFTER INTERVERTEBRAL BODY FUSION SURGERY. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING SPINE SURGERIES. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 29 MARCH 2018; LOT 140603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2014 EXPIRATION DATE:2019-03-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 27X35X12 LORDOSIS 15° REFERENCE 03.31.027 (K160605) LOT 143344:50 ITEMS MANUFACTURED AND RELEASED ON 05 SEPT 20014. EXPIRATION DATE: 2019-07-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 (DOUBLE PACKAGING) REFERENCE 03.30.121 (K124034) LOT 148227: 120 ITEMS MANUFACTURED AND RELEASED ON 05 SEPT 2016. EXPIRATION DATE: 2021-08-24 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT A SIMILAR REPORTED EVENT (2 ITEMS OF THIS LOT INVOLVED IN THIS COMPLAINT) MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 (DOUBLE PACKAGING) REFERENCE 03.30.122 (K124034) LOT 140626 164 ITEMS MANUFACTURED AND RELEASED ON 07 AUGUST 2014. EXPIRATION DATE: 2019-06-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 137 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT (2 PIECES OF THIS LOT INVOLVED IN THIS COMPLAINT)

    Description of Event or Problem · 1

    ABOUT 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224589 MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM ANTERIOR STAND-ALONE PLATE FLUSH OVD MEDACTA INTERNATIONAL SA 140603 07630030833557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention