BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 DEFORMITY SYSTEM

    MDR report key: 1635680 · Received March 19, 2010

    Report

    Report Number
    2242816-2010-00036
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT, A REVISION SURGERY WAS CONDUCTED TO RE-TIGHTEN HARDWARE AS TWO DEROTATION PLUGS ON THE RIGHT SIDE OF THE SCOLIOSIS CONSTRUCT WERE 'LOOSE' AND MAY AVE BACKED OUT BY A FEW THREADS. PLUGS WERE REMOVED AND REPLACED, ENTIRE CONSTRUCT WAS RE-TIGHTENED. PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS 5.5 DEFORMITY SYSTEM SST DEROTATION HELICAL FLANGE PLUG MNH EBI, LLC 2168142

    Patients

    Seq Age Sex Outcome Treatment
    1