BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEXTANT

    MDR report key: 2010402 · Received March 1, 2011

    Report

    Report Number
    MW5019661
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 16, 2011
    Report Date
    March 1, 2011
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2004, PT UNDERWENT SPINAL SURGERY AT L4-5 WITH PEEK PR CAGES AND PEDICLE SCREWS AND RODS. ON (B)(6) 2011, SHE REPORTS FALLING ON ICE WITH SUBSEQUENT INCREASED PAIN IN HER LOW BACK. CT SCAN REVEALED GOOD FUSION AT BOTH L4 AND L% AND A FRACTURE OF THE PEDICLE SCREW WITHOUT DISPLACEMENT AT L5. IT WAS RECOMMENDED THAT SHE HAVE THE SCREWS REMOVED IN LIGHT OF THE GOOD FUSION. SHE RETURNED TO OPERATING ROOM ON (B)(6) 2011 FOR REMOVAL OF THE PEDICLE SCREWS AND PERCUTANEOUS ROD. DIAGNOSIS OR REASON FOR USE: DEGENERATIVE DISC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEXTANT PEDICLE SCREW KWP 07/22/04

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR