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NUBIC

SIGNUS Medizintechnik GmbH · Model Cervical cage with strut · UDI-DI 04047844002018

MQP ODP OVE Prescription

510(k) clearances

2,930

Adverse events (14 deaths)

Recalls

223

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
2022-11-10	NuVasive Inc	Potential that insert will be unable to disengage from the vertebral body replacement device/implant
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21	Synthes (USA) Products LLC	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

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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.