CD HORIZON Spinal SystemRecalls & reported problems across all models

We found 342 models of CD HORIZON Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 2,323 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 29, 2026 — classified as 2 deaths, 746 injuries, 1,575 malfunctions.

The most frequently reported specific device problem is “Break” (975 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CD HORIZON Spinal System problems

CD HORIZON Spinal System models

342 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• CD HORIZON® Spinal System 7540020

  Orthosis, spondylolisthesis spinal fixation
  257 reports
• CD HORIZON® Spinal System 5540030

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  230 reports
• CD HORIZON® Spinal System 8590855

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  179 reports
• CD HORIZON® Spinal System 7578302

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  122 reports
• CD HORIZON® Spinal System 5440030

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  50 reports
• CD HORIZON® Spinal System 9010000849

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 deaths42 reports
• CD HORIZON® Spinal System 25100401

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  39 reports
• CD HORIZON® Spinal System 1553201090

  ORTHOSIS, SPINAL PEDICLE FIXATION
  38 reports
• CD HORIZON® Spinal System 7540220

  ORTHOSIS, SPINAL PEDICLE FIXATION
  36 reports
• CD HORIZON® Spinal System NAV2020

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  30 reports
• CD HORIZON® Spinal System 8115545

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  28 reports
• CD HORIZON® Spinal System 55840006550

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  27 reports
• CD HORIZON® Spinal System 7576545

  Orthosis, spondylolisthesis spinal fixation
  26 reports
• CD HORIZON® Spinal System 75446540

  ORTHOSIS, SPINAL PEDICLE FIXATION
  22 reports
• CD HORIZON® Spinal System 7640020

  ORTHOSIS, SPINAL PEDICLE FIXATION
  22 reports
• CD HORIZON® Spinal System 55840006545

  Orthosis, spondylolisthesis spinal fixation
  21 reports
• CD HORIZON® Spinal System 75446545

  Orthosis, spondylolisthesis spinal fixation
  21 reports
• CD HORIZON® Spinal System 55840007545

  Orthosis, spondylolisthesis spinal fixation
  20 reports
• CD HORIZON® Spinal System NAV1400

  Orthopedic stereotaxic instrument
  18 reports
• CD HORIZON® Spinal System 5540230

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  17 reports
• CD HORIZON® Spinal System 54840006545

  Orthosis, spondylolisthesis spinal fixation
  16 reports
• CD HORIZON® Spinal System 7570855

  Orthosis, spondylolisthesis spinal fixation
  16 reports
• CD HORIZON® Spinal System 6430530

  Orthosis, spondylolisthesis spinal fixation
  15 reports
• CD HORIZON® Spinal System 75445540

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  15 reports
• CD Horizon® Spinal System 7078396

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  15 reports
• CD HORIZON® Spinal System 55840006540

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  14 reports
• CD HORIZON® Spinal System 55840007550

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  14 reports
• CD HORIZON® Spinal System 25840018580

  Orthopedic stereotaxic instrument
  14 reports
• CD HORIZON® Spinal System 8115539

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  14 reports
• CD HORIZON® Spinal System 55840008580

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  13 reports
• CD HORIZON® Spinal System 5484902

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  13 reports
• CD HORIZON® Spinal System 8110855

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  13 reports
• CD HORIZON® Spinal System 7049855

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  12 reports
• CD HORIZON® Spinal System 8115536

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  12 reports
• CD HORIZON® Spinal System 7576540

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  12 reports
• CD HORIZON® Spinal System 75446550

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  12 reports
• CD HORIZON® Spinal System 1553200500

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  11 reports
• CD HORIZON® Spinal System 55840007540

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  11 reports
• CD HORIZON® Spinal System 1553201070

  ORTHOSIS, SPINAL PEDICLE FIXATION
  11 reports
• CD HORIZON® Spinal System 1555200500

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  11 reports
• CD HORIZON® Spinal System 9010000849

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  11 reports
• CD HORIZON® Spinal System 5442141

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  10 reports
• CD HORIZON® Spinal System 1553201050

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  10 reports
• CD HORIZON® Spinal System 1553201040

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  10 reports
• CD HORIZON® Spinal System NAV2024

  Orthopedic stereotaxic instrument
  10 reports
• CD HORIZON® Spinal System 8690024

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  9 reports
• CD HORIZON® Spinal System 1476000500

  ORTHOSIS, SPINAL PEDICLE FIXATION
  9 reports
• CD HORIZON® Spinal System 54840006550

  Orthosis, spondylolisthesis spinal fixation
  9 reports
• CD Horizon® Spinal System 5530030

  Thoracolumbosacral pedicle screw system
  9 reports
• CD HORIZON® Spinal System 25740018590

  ORTHOSIS, SPINAL PEDICLE FIXATION
  9 reports
• CD HORIZON® Spinal System 7577550

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  9 reports
• CD HORIZON® Spinal System 7575300

  Orthosis, spondylolisthesis spinal fixation
  9 reports
• CD HORIZON® Spinal System 7440020

  ORTHOSIS, SPINAL PEDICLE FIXATION
  9 reports
• CD HORIZON® Spinal System G7540020

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  8 reports
• CD HORIZON® Spinal System 7570905

  ORTHOSIS, SPINAL PEDICLE FIXATION
  8 reports
• CD HORIZON® Spinal System 25740018580

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  8 reports
• CD HORIZON® Spinal System RBT033101

  Orthopedic stereotaxic instrument
  8 reports
• CD Horizon® Spinal System 7078397

  Thoracolumbosacral pedicle screw system
  8 reports
• CD HORIZON® Spinal System 5442147

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  7 reports
• CD HORIZON® Spinal System 1555000500

  Orthosis, spondylolisthesis spinal fixation
  7 reports
• CD HORIZON® Spinal System 1553201100

  ORTHOSIS, SPINAL PEDICLE FIXATION
  7 reports
• CD HORIZON® Spinal System 25740018570

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  7 reports
• CD HORIZON® Spinal System RBT033102

  Orthopedic stereotaxic instrument
  7 reports
• CD HORIZON® Spinal System 7576550

  Orthosis, spondylolisthesis spinal fixation
  7 reports
• CD HORIZON® Spinal System 7577545

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  7 reports
• CD HORIZON® Spinal System 7570955

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  7 reports
• CD HORIZON® Spinal System 54840006540

  Orthosis, spondylolisthesis spinal fixation
  6 reports
• CD HORIZON® Spinal System 5442136

  ORTHOSIS, SPINAL PEDICLE FIXATION
  6 reports
• CD HORIZON® Spinal System 5442138

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  6 reports
• CD HORIZON® Spinal System 54840007540

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  6 reports
• CD HORIZON® Spinal System 779115555

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  6 reports
• CD HORIZON® Spinal System 55840005550

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  6 reports
• CD HORIZON® Spinal System 1554200500

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  6 reports
• CD HORIZON® Spinal System 5540430

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  6 reports
• CD HORIZON® Spinal System X0311334

  ORTHOSIS, SPINAL PEDICLE FIXATION
  6 reports
• CD Horizon® Spinal System 1604300500

  Thoracolumbosacral pedicle screw system
  6 reports
• CD HORIZON® Spinal System 55740106545

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  6 reports
• CD HORIZON® Spinal System NAV2002

  Orthosis, spondylolisthesis spinal fixation
  6 reports
• CD HORIZON® Spinal System 8690060

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  6 reports
• CD HORIZON® Spinal System 8115528

  Orthosis, spondylolisthesis spinal fixation
  6 reports
• CD HORIZON® Spinal System 8116445

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  6 reports
• CD HORIZON® Spinal System 7543645

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  6 reports
• CD HORIZON® Spinal System 7570900

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• CD HORIZON® Spinal System 7570901

  POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
  5 reports
• CD HORIZON® Spinal System 54840016540

  ORTHOSIS, SPINAL PEDICLE FIXATION
  5 reports
• CD HORIZON® Spinal System 55840006535

  Orthosis, spondylolisthesis spinal fixation
  5 reports
• CD HORIZON® Spinal System 55740106550

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  5 reports
• CD HORIZON® Spinal System 55840016545

  Orthosis, spondylolisthesis spinal fixation
  5 reports
• CD HORIZON® Spinal System NAV2023

  ORTHOSIS, SPINAL PEDICLE FIXATION
  5 reports
• CD HORIZON® Spinal System 25740019590

  Orthopedic stereotaxic instrument
  5 reports
• CD HORIZON® Spinal System 869-011

  Orthosis, spondylolisthesis spinal fixation
  5 reports
• CD HORIZON® Spinal System 8116439

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  5 reports
• CD HORIZON® Spinal System 7575540

  ORTHOSIS, SPINAL PEDICLE FIXATION
  5 reports
• CD HORIZON® Spinal System 75445545

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  5 reports
• CD HORIZON® Spinal System 75446535

  Orthosis, spondylolisthesis spinal fixation
  5 reports
• CD HORIZON® Spinal System 7226550

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  5 reports
• CD HORIZON® Spinal System 7896545

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  4 reports
• CD HORIZON® Spinal System 55840006555

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  4 reports
• CD HORIZON® Spinal System 1604200500

  ORTHOSIS, SPINAL PEDICLE FIXATION
  4 reports
• CD Horizon® Spinal System 55740007545

  Appliance, fixation, spinal intervertebral body
  4 reports

Recent CD HORIZON Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for L3-IL rear fixation + L5/S Posterior Lumbar Interbody Fusion and Hernia LCS was the preoperative diagnosis of this surgery and there was a less than 60 mins delay in the overall procedure time. It was reported that all rods were installed and the final was performed, but during the final of the Iliac, there was a strange noise and a bur appeared, so the final (thread cutting) could not be finished. Even after replacing the set screw, the same issue occurred, so a new screw was swapped in and the final was performed without any issues. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927337 ↗
• MalfunctionSep 29, 2026Material Deformation

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for L3-IL rear fixation + L5/S Posterior Lumbar Interbody Fusion and Hernia LCS was the preoperative diagnosis of this surgery and there was a less than 60 mins delay in the overall procedure time. It was reported that all rods were installed and the final was performed, but during the final of the Iliac, there was a strange noise and a bur appeared, so the final (thread cutting) could not be finished. Even after replacing the set screw, the same issue occurred, so a new screw was swapped in and the final was performed without any issues. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927334 ↗
• MalfunctionSep 28, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding screws used in Transforaminal Lu mbar Interbody Fusion therapy detected in MRI. It was reported that the screws broke. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911052 ↗
• MalfunctionSep 28, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding screws used in Transforaminal Lu mbar Interbody Fusion therapy detected in MRI. It was reported that the screws broke. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910956 ↗
• MalfunctionSep 25, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Clinical Study) regarding a patient with clinical ID: (b)(4) and study ID: (b)(4) having L3-L5 Posterior Spinal Fixation and Fusion therapy. It was reported that there has been failure of the right iliac set screw with some worsening of his positive sagittal balance and PILL mismatch. There were no patient symptoms reported.  Outcome Status: Recovering/ Resolving Action Type: Diagnostic, Action Subtype: X-RAY-1 Action Result: AP and lateral scoliosis radiographs reveal L3 to ilium fusion with lateral interbody at L3-4 and anterior lumbar interbody fusion L5-S1. There has been failure of the right iliac set screw with some worsening of his positive sagittal balance and PILL mismatch. No other instrumentation failure, Action Date: 2026-09-03 Site Related Assessment: Causal Relationship with Study Device. Sponsor Assessment: sponsor assessment not related to procedure, causal related to device. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893920 ↗
• MalfunctionSep 22, 2026Product Quality Problem; Material Deformation

  Information was received from multiple sources (Manufacturer Representative, Distributor) regarding a device used in a Spinal therap y. It was reported that the set screw was received in damaged condition from the warehouse prior to supply to a hospital. There was no patient involvement in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850867 ↗
• MalfunctionSep 21, 2026Failure to Align

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having lumbar decompre ssion and single-level lumbar fixation therapy for stenosis and degenerative disc disease. It was reported that the set screw was defective and was never implanted. Solera Bop threads were not aligning with screw tulip threads. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837267 ↗
• MalfunctionSep 21, 2026Failure to Align

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having lumbar decompre ssion and single-level lumbar fixation therapy for stenosis and degenerative disc disease. It was reported that the set screw was defective and was never implanted. Solera Bop threads were not aligning with screw tulip threads. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837221 ↗
• MalfunctionSep 21, 2026Failure to Align

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having lumbar decompre ssion and single-level lumbar fixation therapy for stenosis and degenerative disc disease. It was reported that the set screw was defective and was never implanted. Solera Bop threads were not aligning with screw tulip threads. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837202 ↗
• MalfunctionSep 17, 2026Material Deformation

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Distributor) regarding a patient h aving Transforaminal Lumbar Interbody Fusion due to Degenerative Disc Disease. It was reported that set screw thread was stripped during screw tightening and could not be used for the patient.. There were no patient symptoms reported. There were no further complic ations reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797847 ↗
• MalfunctionSep 10, 2026Failure to Align

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having lumbar decompre ssion and single-level lumbar fixation therapy for stenosis and degenerative disc disease. It was reported that the set screw was defective and was never implanted. Solera Bop threads were not aligning with screw tulip threads. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50709489 ↗
• InjurySep 9, 2026Device Dislodged or Dislocated

  Information was received from a healthcare provider regarding a Patient having revision surgery due to adult spinal deformity. In a repeat surgery case for adult spinal deformity following the initial surgery performed on (b)(6) 2024, hook dislodgement at the upper fixed end was reported for products 5531414 SO56 Transverse Hook Light and 5531415 SO56 Transverse Hook Left, both implanted at thoracic vertebra 4. Patient underwent additional surgery to extend the fixation range upward and re-fix the construct following the reported dislodgement. The patient required hospitalization or extended care after discharging due to pressure ulcer and back pain, developed bedsore and back pain.  Bone fusion was reported as not achieved immediately after surgery. There were no further complications reported.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 50686831 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539519 ↗
• MalfunctionAug 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519416 ↗
• InjuryAug 27, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a rod used for revision of two l evel Anterior Lumbar Interbody Fusion therapy and posterior hardware revision for pre-operative diagnosis of spinal stenosis. It was reported that the patient has had multiple procedures done. On (b)(6) 2019, the patient underwent an L3-L5 lumbar spinal fusion. On (b)(6) 2026, the patient had a revision extension spinal fusion spanning T10-Pelvis. Between this surgery and one month follow up on (b)(6) 2026, the patients rods broke just above the S1 screws. On (b)(6) 2026, the patient underwent a revision and had an Anterior Lumbar Interbody Fusion therapy done at L4-L5 and L5-S1 levels and then had a posterior revision where extra pelvic screws were added along with secondary rods for more support. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470131 ↗

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