BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS FCD-2 ANCHOR AND STABILIZER

    MDR report key: 2219662 · Received August 11, 2011

    Report

    Report Number
    2032499-2011-00094
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 11, 2011
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K090767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL# 9063-00, LOT# 091409-B.

    Description of Event or Problem · 1

    PT'S FIRST SURGERY WAS ON (B)(6), 2010 AND FCD-2 SCREWS WERE IMPLANTED AT L3-L4, L4-L5, AND L5-S1. ON (B)(6), 2011, DR. (B)(6) REPLACED A SCREW AT THE L3-L4 LEVEL HAVING DISCOVERED THAT IT FRACTURED. HE THINKS THAT THE FRACTURE WAS DUE TO AN ISSUE WITH HOW THE IMPLANT WAS SEATED. PT RECOVERED SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS FCD-2 ANCHOR AND STABILIZER MRW INTERVENTIONAL SPINE, INC. 9062-00 091409-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention