BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SPINE

    MDR report key: 7470420 · Received April 27, 2018

    Report

    Report Number
    3004499989-2018-00003
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 28, 2018
    Manufacturer
    LIFE SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K132589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SURGERY, THE DRILL BIT BENT AND WHEN TRYING TO BACK OUT THE DRILL BIT THE TIP BROKE OFF AND WAS RETAINED IN THE PATIENT. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD EXISTING SPINAL HARDWARE THAT THE DRILL BIT COULD HAVE COME IN CONTACT WITH TO CAUSE THE DRILL BIT TO BEND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE DRILL BIT BENT IN USE AND WHEN THE SURGEON TRIED TO BACK THE DRILL BIT OUT THAT THE DRILL BIT BROKE OFF AND WAS RETAINED IN THE PATIENT. THE PATIENT DID HAVE EXISTING SPINAL HARDWARE IN THE NEAR VICINITY THAT COULD HAVE CAUSED THE DRILL BIT TO BEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312005 LIFE SPINE ADJUSTABLE DRILL KWQ LIFE SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other