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CD HORIZON® SOLERA® Spinal System

MEDTRONIC SOFAMOR DANEK, INC. · Model 641000075 · UDI-DI 00643169491052

HBE MNH OLO NKB KWQ MNI KWP OSH Prescription

510(k) clearances

22,777

Adverse events (3 deaths)

258

Recalls

140

Facilities

Description

ROD 641000075 75MM PERC ROD 4.75MM CCM

Recalls

Date	Firm	Reason
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30	SURGIFY MEDICAL OY	Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

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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.