CYLOX ST 12°
SIGNUS Medizintechnik GmbH · Model Cervical cage, angled · UDI-DI 04047844123782
Description
The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of interbodies, plates, and screws. The interbody device can be used as a stand alone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V). The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central hole and two holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-23 | Stryker Spine | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed. |
| 2021-09-08 | K2M, Inc | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative |
| 2021-09-02 | Medtronic Sofamor Danek USA Inc | Engraving on implants may not match what is listed on the pouch labels. |
| 2019-06-13 | SpineFrontier, Inc. | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
| 2019-01-30 | U&I CORP. | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability |
| 2017-07-07 | Amendia, Inc | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in len |
| 2016-11-22 | Amendia, Inc | Absent tantalum market pin. |
| 2015-09-28 | Exactech, Inc. | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One |
| 2015-07-20 | TITAN SPINE, LLC | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. |
| 2015-02-20 | TITAN SPINE, LLC | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, |
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