Posterior Metal/polymer Spinal System, Fusion
Orthopedic · 21 CFR 888.3070
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Recent MDR events
848 adverse event reports on file
- CD HORIZON® SPINAL SYSTEMFeb 26, 2026InjuryMsd Deggendorf Mfg3011795235-2026-00010
- UNKNOWNFeb 26, 2026InjuryMsd Deggendorf Mfg3011795235-2026-00011
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMFeb 9, 2026InjuryMsd Deggendorf Mfg3011795235-2026-00005
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMFeb 9, 2026InjuryMsd Deggendorf Mfg3011795235-2026-00006
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMDec 26, 2025InjuryMsd Deggendorf Mfg3011795235-2025-00027
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMDec 26, 2025InjuryMsd Deggendorf Mfg3011795235-2025-00028
- TRANSITION STABILIZATION SYSTEMSep 29, 2025MalfunctionGlobus Medical, Inc.3004142400-2025-00211
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMMay 4, 2025InjuryMsd Deggendorf Mfg1030489-2025-01866
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMApr 25, 2025InjuryMsd Deggendorf Mfg1030489-2025-01838
- CD HORIZON® ASTUTE¿ SPINAL SYSTEMApr 24, 2025MalfunctionMsd Deggendorf Mfg1030489-2025-01828
Event type breakdown
Recalls
50 recall events for this product code
- Zimmer, Inc.TerminatedNov 6, 2012
Dynesys Set screw M6
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0236-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 6, 2012
Dynesys Universal spacer 6-45
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0237-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 6, 2012
Dynesys Revision + set screw
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0239-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 6, 2012
Dynesys HA Pedicle + set screw
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0240-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 6, 2012
DTO" Implant
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0241-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 6, 2012
Dynesys Top-Loading System Cannulated Pedicle + Set Screw
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0242-2013 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedSep 1, 2010
TI N-Hance Rod 150mm Sterile
package integrity compromised
Z-2344-2010 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedSep 1, 2010
N-Hance System 150mm
package integrity compromised
Z-2345-2010 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedSep 1, 2010
NFix II System 150mm
package integrity compromised
Z-2346-2010 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedSep 1, 2010
NFlex Straight monosegmental L 150mm
package integrity compromised
Z-2347-2010 · View FDA record ↗
Registered firms
144 firms currently registered for this product code
Isomedix Operations Inc.
SAN DIEGO, CA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Aps Materials Suzhou
Suzhou Jiangsu, CN
Medtronic Medical Costa Rica S.r.l.
Coyol Alajuela, CR
Medtronic Puerto Rico Operations Co., Humacao
HUMACAO, PR, US
First Article Inc
Souderton, PA, US
Globus Medical, Inc.
AUDUBON, PA, US
Culver Tool & Engineering
Plymouth, IN, US
B & G Mfg. Co.
HATFIELD, PA, US
Flex-cell Precision, Inc.
Lancaster, PA, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Branch Medical Group
Limerick, PA, US
Axial Medical
Ivyland, PA, US
Orchid Orthopedic Solutions Alabama Llc
Arab, AL, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
510(k) clearances
22 clearances for this product code
- Medtronic Sofamor Danek USA, Inc.Jan 15, 2021
K203678 · CD HORIZON Spinal System
- Medtronic Sofamor Danek USA, Inc.Oct 3, 2019
K191066 · CD Horizon Astute Spinal System
- Medtronic Sofamor Danek USA, Inc.Jan 11, 2019
K182928 · CD Horizon Spinal System
- Zimmer Spine, Inc.Jan 16, 2014
K133164 · DYNESYS TOP-LOADING SPINAL SYSTEM
- Zimmer Spine, Inc.Aug 18, 2010
K101704 · ZIMMER DTO PIN PRESS INSTRUMENT
- Paradigm Spine, LLCJul 2, 2010
K101083 · DSS STABILIZATION SYSTEM
- Zimmer Spine, Inc.Oct 1, 2009
K092234 · DYNESYS TOP-LOADING SPINAL SYSTEM
- Paradigm Spine, LLCAug 3, 2009
K091944 · MODIFICATION TO: DSS STABILIZATION SYSTEM