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RABEA 5°

SIGNUS Medizintechnik GmbH · Model Cervical cage, angled · UDI-DI 04047844000649

OVE MQP ODP Prescription

510(k) clearances

2,375

Adverse events

Recalls

234

Facilities

Description

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.