BEUDAMED
    412 results · 134ms · Sources: EU EUDAMED, US FDA

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    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code MAX·July 2, 2015

    SPIDER CERVICAL PLATING SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code KWQ·February 4, 2011

    SPIDER 2 LEVEL 39MM PLATE

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code KWQ·March 8, 2012

    SPIDER 3 LEVEL 59MM PLATE

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code KWQ·March 8, 2012

    XPRESS SYSTEM PEDICLE SCREW SYSTEM , X90 PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code MNI·February 6, 2018

    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    FDA Enforcement
    Class II ·Terminated·X Spine Systems Inc·July 1, 2015

    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    FDA Recall
    Terminated ·X Spine Systems Inc·Product code MNH·April 7, 2015

    Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

    FDA Recall
    Terminated ·X Spine Systems Inc·Product code MNH·March 24, 2009

    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.

    FDA Recall
    Terminated ·X Spine Systems Inc·Product code MNH·March 11, 2015

    SPIDER CERVICAL PLATING (SCP) SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code KWQ·December 2, 2016

    IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code OVD·December 13, 2016

    IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code OVD·December 13, 2016

    ARANAX ANTERIOR CERVICAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code KWQ·October 21, 2016

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code OVE·November 23, 2016

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code MAX·September 11, 2015

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS, INC.·Product code MAX·September 9, 2015

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code MAX·September 11, 2015

    SPIDER CERVICAL PLATES

    FDA Adverse Event
    Malfunction ·X-SPINE SYSTEMS INC.·Product code KWQ·August 21, 2015

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code MAX·September 11, 2015

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code MAX·September 11, 2015