BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI 9X22X12 L5

    MDR report key: 11037512 · Received December 18, 2020

    Report

    Report Number
    3005180920-2020-00952
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630040719452
    PMA / PMN Number
    K181970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 DECEMBER 2020: LOT 1922752: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2019. EXPIRATION DATE: 2024-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. NOTE THAT TWO EQUAL DEVICES (SAME REF AND LOT) HAVE BEEN REPORTED IN THIS CASE. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE CAGES REF 03.27.115, LOT NO. 1922752 DO NOT PRESENT ANY SIGNS OF DAMAGE OR OF DEFORMATION. THE PARTS ARE ACCORDING TO THE SPECIFICATIONS. ACCORDING TO THE DESCRIPTION OF THE EVENT, THE ROOT CAUSE OF THE COMPLAINT (THE BACKOUT OF THE IMPLANTS) COULD BE THE PHYSICAL ALTERCATION THAT THE PATIENT HAD WITH THE NURSE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. POST-OP X-RAYS INDICATED THAT CAGES EJECTED INTO THE CANAL AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED THE CAGES 28 DAYS AFTER PRIMARY AND DID NOT PUT ANY IMPLANTS IN TO REPLACE THEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT SHOULD BE NOTED THAT THE PATIENT GOT INTO A PHYSICAL ALTERCATION IN POST-OP CARE. THIS IS MOST LIKELY THE REASON WHY THE CAGES ENDED UP FREE FLOATING. THE AGENT THINKS THE SURGEON MAY HAVE PUT BONE GRAFT IN PLACE BUT IS NOT 100% CERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505698 MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI 9X22X12 L5 INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 1922752 07630040719452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention