Home › Pioneer Surgical Technology, Inc. › SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM

SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM

Pioneer Surgical Technology, Inc. · Model 21-118-D · UDI-DI 00846468024994

KWQ Prescription

510(k) clearances

10,554

Adverse events (59 deaths)

214

Recalls

359

Facilities

Description

SlimFuse Asm, Dyn, 1 Level, 18mm

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.