BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 / BALLISTA SPINAL SYSTEM IMPLANTS & INSTRUMENTS

    MDR report key: 2983361 · Received February 28, 2013

    Report

    Report Number
    0002242816-2013-00013
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    EBI, LLC.
    Product Code
    HXX
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION CONFIRMED THE REPORTED EVENT. THE TIP OF THE INNER SHAFT WAS SHEARED OFF. ON THE PORTION OF THE TIP STILL INTACT THE INSTRUMENT WAS DEFORMED IN A TORQUING MANNER. HARDNESS TESTING OF THE RETURNED PRODUCT CONFIRMED PROPER MANUFACTURING AND PROCESSING. THE MANUFACTURING RECORD WAS REVIEWED FINDING A DMRR WHERE THE INSTRUMENTS WERE ACCEPTED AND USED AS IS; NO OTHER ANOMALIES WERE FOUND IN THE DOCUMENTATION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE DAMAGE IS EXCESSIVE TORQUE FORCES LEADING TO LOSS OF MECHANICAL INTEGRITY AND ULTIMATELY INSTRUMENT FRACTURE DURING USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING INSERTION OF THE SCREW. THE TIP BROKE OFF INTO THE SCREWHEAD AND REMAINS IMPLANTED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87372 POLARIS 5.5 / BALLISTA SPINAL SYSTEM IMPLANTS & INSTRUMENTS MULTI-AXIAL SCREW INSERTER HXX EBI, LLC. N/A PR17A

    Patients

    Seq Age Sex Outcome Treatment
    1