BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESPINE

    MDR report key: 10430607 · Received August 20, 2020

    Report

    Report Number
    3004499989-2020-00006
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 24, 2020
    Manufacturer
    LIFE SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00190837031084
    PMA / PMN Number
    K190488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    TIP OF SHAVER BROKEN DURING SURGERY AND DELAYED SURGERY 40 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897791 LIFESPINE PROLIFT MAX LIFE SPINE, INC. 151-265 UNKNOWN 00190837031084

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other