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CD Horizon™ Astute™ Spinal System

MEDTRONIC SOFAMOR DANEK, INC. · Model 1608451040 · UDI-DI 00763000312947

KWQ NQP KWP NKB Prescription

510(k) clearances

10,554

Adverse events (59 deaths)

214

Recalls

359

Facilities

Description

PEEK ROD 1608451040 6.0 X 6.9MM STR 40MM

Recalls

Date	Firm	Reason
2026-02-20	Clariance-SAS	Due to a quality issue regarding the presence of burr on the finished cervical plate product.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
2021-04-26	Alphatec Spine, Inc.	There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

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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.