BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FCD-2

    MDR report key: 2062408 · Received March 18, 2011

    Report

    Report Number
    2032499-2011-00090
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 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

    METHOD OF EVALUATION WAS INTERVIEWING THE COMPANY STAFF PRESENT AT THE CASE: PATIENT EXHIBITED NO PAIN OR COMPLAINTS. REMOVED STABILIZER AND 3 THREADS OF THE ANCHOR. DOCTOR'S COMMENTS: " PROBABLY PLACED TOO MEDIAL." PLACING THE IMPLANT TOO MEDIAL CAN RESULT IN UNDUE STRESS ON IMPLANT, CAUSING IT TO BREAK. INSPECTION OF THE IMPLANT OBSERVED A CLEAN BREAK AT AN ANGLE; PROBABLY SOME SORT OF SHEAR BREAK. TRAJECTORY OF ENTRY POINT AND PLACEMENT ARE CRITICAL AND ARE EXPLICITLY DEFINED IN THE SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    FOLLOW-UP X-RAY REVEALED THAT THE SCREW PLACED AT L1-L-2 ON LEFT LOOKED BENT. IMPLANT WAS PLACED ON (B)(6) 2010. IMPLANT WAS REMOVED AND FOUND TO BE BROKEN AT SCREW. A NEW IMPLANT WAS PLACED NEXT TO PIECE THAT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FCD-2 MRW INTERVENTIONAL SPINE, INC. 9063-00 062009-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention