BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-CIFT SOLOFUSE

    MDR report key: 8621996 · Received May 17, 2019

    Report

    Report Number
    3005977257-2019-00007
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    January 25, 2019
    Report Date
    May 17, 2019
    Manufacturer
    SPINEFRONTIER INC
    Product Code
    OVE
    UDI-DI
    00190361021575
    PMA / PMN Number
    K151198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPINEFRONTIER INVESTIGATION INTO THIS MATTER DETERMINED THAT THE PRODUCT FAILURE WAS NOT RELATED TO MANUFACTURING, MATERIALS, ASSEMBLY, INSPECTION, CONFORMANCE, COMPLIANCE, RISK MITIGATION OR SURGICAL PROCEDURAL SPECIFICATIONS. MISUSE SCENARIOS, OVERTIGHTENING OF THE INSERTER TO THE INTERBODY, OVER IMPACTION INTO THE VERTEBRAE AND CROSS-THREADING, MOST LIKELY CAUSED THE CRACK TO OCCUR. THESE FAILURES ARE THE RESULTS OF USER ERROR AND COULD HAVE BEEN MITIGATED THROUGH MORE CAREFUL ATTACHMENT AND GENTLE IMPACTION. HEEDING THE WARNINGS IN THE SURGICAL PROCEDURE WILL PREVENT RE-OCCURRENCE. A REVIEW OF THE A-CIFT FMEA, ACCOUNTED FOR INSERTER DAMAGING THE IMPLANT DUE TO THE CAGE MATERIAL (PEEK) NOT BEING STRONG ENOUGH AND/OR IMPROPER ASSEMBLY OF THE IMPLANT ON TO THE INSERTER AND THE RISK OF THE IMPLANT BEING DAMAGED DURING INSERTION DUE TO EXCESSIVE IMPACTION. SPINEFRONTIER IS CONSIDERING THE INVESTIGATION INTO THIS MATTER CLOSED, WITHOUT THE NEED FOR ANY FURTHER ACTION.

    Description of Event or Problem · 1

    SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE 6MM A-CIFT SOLOFUSE INTERBODY WAS OBSERVED TO BE CRACKED WHEN ATTEMPTING TO PLACE THE SCREWS, A MALLET WAS USED TO POSITION THE IMPLANT. THERE WAS NO IMPACT TO PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415024 A-CIFT SOLOFUSE A-CIFT SOLOFUSE OVE SPINEFRONTIER INC 01-32017-06 BC05 00190361021575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention