BEUDAMED
    FDA Recall Terminated

    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Recall: Z-2616-2014 · Initiated June 14, 2013

    Recall

    Recall Number
    Z-2616-2014
    Event Number
    69036
    Firm
    PIONEER SURGICAL TECHNOLOGY, INC.
    FEI Number
    1000115331
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 14, 2013
    Posted
    September 9, 2014
    Terminated
    September 30, 2014
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Reason

    The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

    Action

    Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

    Distribution

    Nationwide Distribution including TX, CA, IL, and FL.

    Quantity

    9