Thoracolumbosacral pedicle screw system

FDA product code NKB · Class 2 · 803 devices · 3,309 reports · 7 deaths reported · 136 devices named in recalls

• VITALITY® 701M6540

  Biomet Spine LLC · Thoracolumbosacral pedicle screw system
  7 reports
• ReLine 16027545

  Nuvasive, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  7 reports
• XIA 3 482318545

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  7 reports
• XIA 3 48230141

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  7 reports
• VIPER 179704990

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  7 reports
• VIPER PRIME 186750445S

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  7 reports
• MESA® Spinal System 801-06545

  VB Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  7 reports
• FIREBIRD NXG 36-2001

  Orthofix US LLC · Thoracolumbosacral pedicle screw system
  7 reports
• CD Horizon® Spinal System 1604300500

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  6 reports
• CD HORIZON® Fenestrated Screw Set 55750027540

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  6 reports
• Vital™ 801M4545

  Biomet Spine LLC · Thoracolumbosacral pedicle screw system
  6 reports
• Medicrea|UNiD ROD B33125599-02

  Medicrea International · Thoracolumbosacral pedicle screw system
  6 reports
• XIA II 03820645

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• ES2 SPINAL SYSTEM 482802650

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• ES2 SPINAL SYSTEM 482804750

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• Xia 3 System - Serrato 482616540

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  6 reports
• icotec Pedicle System, Nut Screw, Ti 16-57-41000

  icotec AG · Thoracolumbosacral Pedicle Screw System
  6 reports
• EXPEDIUM 179702645

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• VIPER 186715850

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• MOUNTAINEER 188362025

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  6 reports
• EXPEDIUM SFX 189401404

  Depuy Spine, LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• Salvo® Spine System 11-6401

  Spine Wave, Inc. · Thoracolumbosacral Pedicle Screw System
  6 reports
• EVEREST® Spinal System 2901-10001-SG

  VB Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• CD HORIZON® Spinal System 7570900

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• CD Horizon™ ModuLeX™ Spinal System 559200009

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  5 reports
• Momentum UU052-30-0500

  Ulrich Medical Usa, Inc. · Thoracolumbosacral Pedicle Screw System
  5 reports
• VITALITY®+ POWER 731M0000

  Biomet Spine LLC · Thoracolumbosacral pedicle screw system
  5 reports
• CD HORIZON® Spinal System 7226550

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• ReLine 15360500

  Nuvasive, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• PathFinder NXT® 3572-1

  Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• Vital Spinal Fixation System 07.02010.001

  Highridge Medical, LLC · Thoracolumbosacral pedicle screw system
  5 reports
• uCentum™ comprehensive posterior system CS 3802-065-045

  Ulrich GmbH & Co. KG · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• XIA II 03821645

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• XIA 3 482317555

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• Xia 3 System - Serrato 482677580

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  5 reports
• EXPEDIUM 179715640

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• EXPEDIUM 196791385

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• Salvo® Spine System 11-6400

  Spine Wave, Inc. · Thoracolumbosacral Pedicle Screw System
  5 reports
• MESA® Spinal System 801-36540M

  VB Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• CD HORIZON® Spinal System 55840008590

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016550

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  4 reports
• CD Horizon™ ModuLeX™ Spinal System 55904506545

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  4 reports
• Pagoda 158-3500-01A

  Ortho Development Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• Response Spine 5.5/6.0 System 00-1300-0645

  Orthopediatrics Corp. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• Response 5.5/6.0 Spine System 01-1300-6000

  Orthopediatrics Corp. · Thoracolumbosacral pedicle screw system
  4 reports
• VITALITY® 701M7550

  Biomet Spine LLC · Thoracolumbosacral pedicle screw system
  4 reports
• MAS PLIF 7070000

  Nuvasive, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• CREO 1067.4745

  Globus Medical, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• CREO 5119.6645

  Globus Medical, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• CREO 1119.0011

  Globus Medical, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• Medicrea|UNiD ROD B33226099-02

  Medicrea International · Thoracolumbosacral pedicle screw system
  4 reports
• XIA 3 482319580

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• CarboClear Pedicle Screw System Pedicle Screw - Non Cannulated

  Carbofix Orthopedics Ltd · Thoracolumbosacral Pedicle Screw System
  4 reports
• ES2 SPINAL SYSTEM 482804745

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• ES2 SPINAL SYSTEM 482804760

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• ES2 SPINAL SYSTEM 482802880

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• Xia 3 System - Serrato 482617545

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  4 reports
• Xia 3 System - Serrato 482617050

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  4 reports
• Xia 3 System - Serrato 482618570

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  4 reports
• Xia 3 System - Serrato 482678580

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  4 reports
• EXPEDIUM 179712740S

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• EXPEDIUM 179772095S

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• EXPEDIUM 196791455

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• EXPEDIUM VERSE 199721850

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  4 reports
• VIPER PRIME 186770245

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  4 reports
• EXPEDIUM ALTALYNE VIPER 1797-96-601S

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  4 reports
• TRIALTIS 5560-12-4530FS

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  4 reports
• TRIALTIS 5560-12-4535FS

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  4 reports
• TRIALTIS 5560-55-3065T

  Medos International Sàrl · Thoracolumbosacral pedicle screw system
  4 reports
• Salvo™ Spine System 11-6530

  Spine Wave, Inc. · Thoracolumbosacral Pedicle Screw System
  4 reports
• Daytona 76-0030

  Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system
  4 reports
• Invictus OsseoScrew 16183-050

  Alphatec Spine, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• Invictus 55405-095-100

  Alphatec Spine, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• Modular Fixation System 165-001

  Life Spine, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• CD HORIZON® Spinal System 54840007545

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• TSRH® Spinal System 1556000500

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• CD HORIZON® Spinal System 55840014540

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• CD HORIZON® Spinal System NAV2025

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750046540

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• n/a 6550014

  Medtronic Sofamor Danek, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• LineSider LS-TU7S5560

  Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
  3 reports
• OsseoScrew 53165-50

  Alphatec Spine, Inc. · Thoracolumbosacral pedicle screw system
  3 reports
• Arsenal 47027

  Alphatec Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• CD HORIZON® Spinal System 7226540

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• CD HORIZON® Spinal System 7191545

  Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• ReLine 16024530

  Nuvasive, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• uCentum™ comprehensive posterior system CS 3802-075-045

  Ulrich GmbH & Co. KG · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• uCentum™ comprehensive posterior system CS 3810-03

  Ulrich GmbH & Co. KG · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• XIA 3 482316535

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• XIA 3 48230133

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• ES2 SPINAL SYSTEM 482804740

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• XIA 4 5 481322040

  Stryker Corporation · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 reports
• Xia 3 System - Serrato 4826195100

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  3 reports
• Xia 3 System - Serrato 482619580

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  3 reports
• Xia 3 System - Serrato 482618550

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  3 reports
• Xia 3 System - Serrato 482617550

  Stryker Corporation · Thoracolumbosacral pedicle screw system
  3 reports
• M.U.S.T. Reduction Pedicle Screws 03.52.731

  Medacta International SA · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
  3 reports
• M.U.S.T. Midline Cortical (MC) Screw System 03.58.244

  Medacta International SA · Thoracolumbosacral Pedicle Screw System
  3 reports
• M.U.S.T. Midline Cortical (MC) Screw System 03.58.264

  Medacta International SA · Thoracolumbosacral Pedicle Screw System
  3 reports
• M.U.S.T. Midline Cortical (MC) Screw System 03.58.265

  Medacta International SA · Thoracolumbosacral Pedicle Screw System
  3 reports