Bone Cement, Posterior Screw Augmentation
Orthopedic · 21 CFR 888.3027
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Recent MDR events
310 adverse event reports on file
- CD HORIZON® Fenestrated Screw Spinal SystemJul 30, 2026MalfunctionMedtronic Puerto Rico Operations Co., Hu2647346-2026-00410
- CD HORIZON® Fenestrated Screw Spinal SystemJul 30, 2026MalfunctionMedtronic Puerto Rico Operations Co., Hu2647346-2026-00411
- CD HORIZON® Fenestrated Screw Spinal SystemJul 30, 2026MalfunctionMdt Puerto Rico Operations Co, Med Rel2647346-2026-00413
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 22, 2026MalfunctionMdt Puerto Rico Operations Co, Med Rel2647346-2026-00397
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 22, 2026InjuryMedtronic Puerto Rico Operations Co., Hu2647346-2026-00404
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 20, 2026MalfunctionMdt Puerto Rico Operations Co, Med Rel2647346-2026-00393
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 15, 2026InjuryMdt Puerto Rico Operations Co, Med Rel2647346-2026-00387
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 14, 2026InjuryMdt Puerto Rico Operations Co, Med Rel2647346-2026-00385
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJul 10, 2026MalfunctionMdt Puerto Rico Operations Co, Med Rel2647346-2026-00380
- CD HORIZON® FENESTRATED SCREW SPINAL SYSTEMJun 27, 2026MalfunctionMdt Puerto Rico Operations Co, Med Rel2647346-2026-00343
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Icotec AgOpen, ClassifiedJan 10, 2024
VADER pedicle system, torque wrench, Catalog Number 42-702
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
Z-0700-2024 · View FDA record ↗ - Icotec AgOpen, ClassifiedJan 10, 2024
VADER pedicle system, torque wrench, Catalog Number 42-703
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
Z-0701-2024 · View FDA record ↗
Registered firms
148 firms currently registered for this product code
Neo Spine Usa Inc.
Hackensack, NJ, US
Ulrich Medical Usa, Inc.
Plano, TX, US
Icotec Ag
Altstaetten Sankt Gallen, CH
Carbofix Orthopedics, Ltd.
Herzeliya Central, IL
Stryker Instruments
Portage, MI, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Insert Molding Solutions, Inc.
Cumming, GA, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Medos International Sarl
Le Locle Neuchatel, CH
Harwood Design, Inc.
Bristol, PA, US
Medtronic Medical Costa Rica S.r.l.
Coyol Alajuela, CR
Neo Medical S.a.
Villette (Lavaux) Vaud, CH
Tomz Corporation
Berlin, CT, US
Friedrich Daniels Gmbh
SOLINGEN North Rhine-Westphalia, DE
Arch Medical Solutions - Seabrook
SEABROOK, NH, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Spineart Sa
Plan-les-Ouates Geneve, CH
Branch Medical Group
Limerick, PA, US
Medtronic (changzhou) Medical Devices Technology Co., Ltd
Changzhou Jiangsu, CN
Globus Medical, Inc.
Memphis, TN, US
510(k) clearances
19 clearances for this product code
- Spine Wave, Inc.Jun 15, 2026
K260286 · Dynamo Spinal Cement; Salvo® Spine System
- Astura MedicalJan 22, 2026
K252885 · OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- Medacta International S.A.Jun 12, 2024
K241034 · Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- Ulrich Medical USAOct 20, 2023
K231809 · Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
- SpineartJun 23, 2023
K230774 · PERLA® TL System; TEKTONA® HV US Bone Cement
- Icotec AGJan 9, 2023
K222789 · VADER® Pedicle System, G21 Cement
- Alphatec Spine, Inc.Dec 20, 2022
K221926 · Invictus® Bone Cement, Invictus Spinal Fixation System
- Neo Medical SAAug 26, 2022
K222256 · BonOs® Inject Bone Cement; NEO Pedicle Screw System