BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 STANDARD IMPLANT KIT

    MDR report key: 3960130 · Received July 28, 2014

    Report

    Report Number
    0002242816-2014-00058
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION CONFIRMED THE REPORTED EVENT. THE TIP OF THE INSTRUMENT WAS SHEARED OFF. DUE TO THE CONDITION OF THE RETURNED INSTRUMENT A FUNCTIONAL EXAMINATION WAS NOT PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES REPORTED AT INSPECTION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE DAMAGE IS EXCESSIVE FORCES LEADING TO LOSS OF MECHANICAL INTEGRITY AND ULTIMATELY INSTRUMENT FRACTURE DURING USAGE OF THE DEVICE. FILE ONE OF TWO, SEE 2242816-2014-00059.

    Description of Event or Problem · 1

    DURING A REVISION SURGERY IT WAS REPORTED THE SURGEON WAS ATTEMPTING TO INSERT A SCREW WHEN THE TIP OF THE INSERTER BROKE, THE SCREW WAS LEFT PROUD. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437656 POLARIS 5.5 STANDARD IMPLANT KIT POLARIS 5.5 BUTTON LOCK SCREW KWP EBI, LLC N/A PU95A

    Patients

    Seq Age Sex Outcome Treatment
    1