BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P-LIFT

    MDR report key: 8622120 · Received May 17, 2019

    Report

    Report Number
    3005977257-2019-00009
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    September 22, 2018
    Report Date
    May 17, 2019
    Manufacturer
    SPINEFRONTIER INC
    Product Code
    MAX
    PMA / PMN Number
    K111553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. SPINEFRONTIER INVESTIGATION INTO THIS MATTER INCLUDED DESIGN OF AN EXPERIMENT USING COMPONENTS FROM THE SAME LOT USED TO MANUFACTURE THE COMPLAINANT DEVICE. THE FAILURE MODE INSERTER BECOMES DISENGAGED DURING IMPACTION WAS SUCCESSFULLY RE-CREATED BASED ON THE FOLLOWING OBSERVATION (KNOB LOOSENING AND EVENTUALLY DISENGAGING FROM THE SHAFT COMPONENT). SIGNS OF WEAR WAS EVIDENT ON BOTH THE SHAFT AND KNOB COMPONENTS. HOWEVER, THE FAILURE MODE ONLY REPLICATED IN SCENARIOS WHEN A WORN KNOB WAS USED WITH A NEW SHAFT, AND IN SCENARIOS WHEN OVER-TIGHTENING OF THE INSERTER ONTO THE IMPLANT. THE RESULTS OF THE EXPERIMENT CONCLUDED THAT THE FAILURE WAS ISOLATED TO ONLY THE KNOB COMPONENT AND ONLY OCCURRED IN SCENARIOS WHERE OVERTIGHTENING WAS A FACTOR. A REVIEW OF THE CURRENT PLIFT FMEA REVEALED DISASSEMBLY IS KNOWN RISKS ASSOCIATED WITH THE INSERTER WITH A RPN VALUE OF 6, WHICH IS LESS THAN ACTIONABLE RISK LEVEL. A REVIEW OF THE P-LIFT INSERTER LABELING ESTABLISHES THERE ARE ADEQUATE LABELING WITH REGARDS TO OVER-TIGHTENING. COMPONENT WEAR IS MITIGATED THROUGH PRE/POST-SURGERY INSPECTION.

    Description of Event or Problem · 1

    SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE P-LIFT INSERTER DISENGAGE DURING IMPACTION, THERE WAS NO IMPACT TO PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414812 P-LIFT P-LIFT MAX SPINEFRONTIER INC 14-06000 A41258MK-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention