BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT MICRO

    MDR report key: 17942066 · Received October 16, 2023

    Report

    Report Number
    3004499989-2023-00020
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 16, 2023
    Manufacturer
    LIFE SPINE
    Product Code
    MAX
    UDI-DI
    00190837141684
    PMA / PMN Number
    D453301K2125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROLIFT MICRO EXPANDABLE SPACER SYSTEM WAS UNABLE TO BE RETURNED TO LIFE SPINE, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE WHAT WAS THE COMPLETE FAILURE MODE RESULTING IN THE REPORTED EVENT. HOWEVER, BASED ON THE DESCRIPTION OF THE EVENT IT IS HYPOTHESIZED THAT THE ROOT CAUSE OF THIS FAILURE WAS LIKELY LOOSENED SET SCREW IN THE PEDICLE SCREW SYSTEM (PEDICLE SCREW SYSTEM NOT A LIFESPINE PRODUCT) LEADING TO COMPROMISED SPINAL STABILITY AND THEREFORE RESULTING IN THE FLIPPING OF THE PROLIFT MICRO EXPANDABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: " [WE] WERE NOTIFIED BY THE SURGEON AND DISTRIBUTOR THAT THE PROLIFT MICRO FLIPPED OVER. THEY THINK IT WAS DUE TO THE SET SCREW FROM ANOTHER PEDICLE SCREW SYSTEM THAT UNATTACHED. THEREFORE, CREATING AN UNSTABLE CONSTRUCT. REVISION SURGERY TO BE SCHEDULED THE WEEK OF SEPT 18TH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506087 PROLIFT MICRO INTERVERTEBRAL BODY FUSION DEVICE MAX LIFE SPINE 58-0832-0813M JZ61 00190837141684

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other