BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDFUSE

    MDR report key: 7481840 · Received May 2, 2018

    Report

    Report Number
    3005977257-2018-00001
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 25, 2018
    Manufacturer
    SPINEFRONTIER, INC
    Product Code
    MNH
    PMA / PMN Number
    K123164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO SPINEFRONTIER FOR EVALUATION, INSTEAD, AN IMAGE OF THE FRACTURED DEVICE WAS RETURNED. SPINEFRONTIER ANALYSED THE IMAGE OF THE FRACTURED IMPLANT, MANUFACTURING RECORDS, COMPLAINT TRENDING AND THE DFMEA AND DETERMINED THAT FAILURE IS DUE TO KNOWN FACTORS (SHEARING AND BENDING AT THE NECK). THE NECK DIAMETER HAS THE SMALLEST CROSS-SECTION OF THE POLYAXIAL SCREW AND AS A RESULT THIS AREA EXPERIENCES THE HIGHEST STRESS. THE SURFACE OF THE BREAK IS MOSTLY PARALLEL TO THE AXIS OF APPLIED FORCE, WHICH IS INDICATIVE OF A SHEAR BREAK. THE BREAK SURFACE IS JAGGED WITH PEAKS (INDICATION OF A BREAK DUE TO BENDING). IN LIGHT OF THIS, IT IS CONCLUDED THAT DEVICE PERFORMED AS DESIGNED AND THEREFORE NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    SPINEFRONTIER BECAME AWARE OF A FRACTURED PEDICLE SCREW OCCURRENCE ON (B)(6) 2018, BASED ON THE INFORMATION RECEIVED, THE PEDICLE SCREW WAS IMPLANTED ON (B)(6) 2017 IN A 21 YEAR OLD MALE PATIENT TO STABILIZE A (L3) POSTERIOR LIGAMENTOUS COMPLEX (PLC) DISTRACTION FOLLOWING A SERIOUS MVA. THE PEDICLE SCREW SUBSEQUENTLY FRACTURED AND THIS WAS DISCOVERED DURING A ROUTINE POST SURGERY FOLLOW-UP VISIT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322848 PEDFUSE PEDFUSE, PRODUCT CODE: MNH MNH SPINEFRONTIER, INC 01-80119-50 BC02

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention