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Sierra™

Seaspine Orthopedics Corporation · Model 50-0535 · UDI-DI 10889910059080

KWP Prescription

510(k) clearances

14,567

Adverse events (40 deaths)

Recalls

322

Facilities

Description

Parallel Rod Connector, 3.5/5.5, Single. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.

Recalls

Date	Firm	Reason
2023-02-16	Medtronic Sofamor Danek USA Inc	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16	Medtronic Sofamor Danek USA Inc	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16	Medtronic Sofamor Danek USA Inc	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16	Medtronic Sofamor Danek USA Inc	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16	Medtronic Sofamor Danek USA Inc	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2022-06-13	K2M, Inc.	Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irrit
2022-01-13	K2M, Inc	Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lot
2022-01-13	K2M, Inc	Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lot
2020-03-26	Medtronic Sofamor Danek USA Inc	Nonconforming product; length of the product measured shorter than the labeled length.
2020-01-28	Medicrea International	An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the re

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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.