BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDFUSE KRD1 PEDICLE SCREW SYSTEM

    MDR report key: 1716603 · Received June 8, 2010

    Report

    Report Number
    3005977257-2010-00001
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 8, 2010
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MNI
    PMA / PMN Number
    K092420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF A FILM FROM THE PROCEDURE SHOWS THAT THE LOCKING CAP WAS NOT PROPERLY SEATED ON THE DEVICE PRIOR TO COMPLETING THE CASE. IT IS LIKELY THAT THE CAP WAS EXPELLED FROM ITS NOT-FULLY-INSERTED POSITION WHEN THE CONSTRUCT WAS EXPOSED TO STRESS INDUCED THROUGH FLEXION, EXTENSION, OR TORSION. DEVICE LABELING PROVIDES A DESCRIPTION OF PROPER LOCKING CAP INSERTION, TOP VIEW AND SIDE VIEW IMAGES OF PROPERLY INSERTED LOCKING CAPS, AND A WARNING ABOUT THE NEED TO ENSURE APPROPRIATE LOCKING CAP INSERTION.

    Description of Event or Problem · 1

    PT HAD RECEIVED A 2-LEVEL LUMBAR PEDICLE SCREW FIXATION L4-S1 ON (B)(6)2010. DURING A POST-OP F/U WITH PT, A LOCKING CAP WAS OBSERVED ON X-RAY TO HAVE MIGRATED FROM THE L4 PEDICLE SCREW ON THE PT'S RIGHT SIDE. PT WAS REVISED ON (B)(6)2010. THE LOCKING CAP WAS REPLACED ON THE SCREW ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDFUSE KRD1 PEDICLE SCREW SYSTEM SPINAL FIXATION DEVICE MNI SPINEFRONTIER, INC. IM80003 174921-000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention