CD HORIZON® Spinal System 5540030Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00613994966476), received between Nov 29, 2016 and Sep 21, 2026 — classified as 58 injuries, 172 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (59 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionApr 21, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT S PINAL PEDICLE SCREW FIXATION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE SPINAL PEDICLE SCREW FIXATION SURGERY AT THE L5¿S1 LEVEL USING A MEDTRONIC SET SCREW, THE SURGEON FOLLOWED THE CORRECT PROTOCOL AND THE INTERNAL LOCKING SCREW WAS FOUND TO HAVE STRIPPED THREADS. THE PRODUCT WAS REPORTED TO HAVE BEEN UTILIZED ACCORDING TO THE DIRECTIONS FOR USE, AND IT DID NOT BREAK. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED, NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THE EVENT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. THE DEVICE WAS REPORTED AS NEVER IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937302 ↗
• MalfunctionMar 25, 2026Failure to Align; Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE BOP COULD NOT THREAD PROPERLY TO THE SCREW, WHICH LED TO INCREASED EFFORT TO THREAD THE BOP WHICH FURTHER DAMAGED THE THREADS ON THE BOP. 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 24684098 ↗
• InjuryFeb 26, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS AT T2-PELVIS. IT WAS REPORTED THAT THE SET CAP DISASSEMBLED FROM THE ROD AND SCREW HEAD. THE PATIENT EXPERIENCED POST-OPERATIVE PAIN. SOLID FUSION WAS ACHIEVED, AS CONFIRMED BY X-RAY IMAGING. NO ADDITIONAL SURGERY OR TREATMENT WAS PERFORMED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO REVISION SURGERY PLANNED.

  Patient problems: Pain

  MAUDE report 24452421 ↗
• MalfunctionFeb 6, 2026Failure to Align; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. PRE-OP DIAGNOSIS WAS PEDIATRIC SCOLIOSIS. IT WAS REPORTED THAT, DURING THE SET SCREW INSERTION IN THE DE-ROTATION STEP, SET SCREWS CROSS-THREAD WITH PEDICLE SCREWS EASILY AND METAL DEBRIS FORMED. PROCEDURE PERFORMED WAS SPINAL FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275524 ↗
• MalfunctionFeb 6, 2026Failure to Align; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. PRE-OP DIAGNOSIS WAS PEDIATRIC SCOLIOSIS. IT WAS REPORTED THAT, DURING THE SET SCREW INSERTION IN THE DE-ROTATION STEP, SET SCREWS CROSS-THREAD WITH PEDICLE SCREWS EASILY AND METAL DEBRIS FORMED. PROCEDURE PERFORMED WAS SPINAL FUSION. THERE WAS NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275519 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6)) L2-L5 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). PATIENT MEDICAL HISTORY: CHRONIC PAIN, LOWER URINARY TRACT INFECTIOUS DISEASE, OBESITY, PRIMARY OSTEOARTHRITIS OF LEFT HIP, SCOLIOSIS OF LUMBAR SPINE, UNSPECIFIED SCOLIOSIS TYPE. INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 FOR WOUND IRRIGATION AND DEBRIDEMENT. IT WAS REPORTED THAT PATIENT HAD WOUND INFECTION AFTER SURGERY WITH SPECIFIC SYMPTOMS OF WOUND DISCHARGE AND VISIBLE DEHISCENCE CAUSING WOUND IRRIGATION AND DEBRIDEMENT PROCEDURE WITH HOSPITALIZATION. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE RELATED ASSESSMENT, EVENT WAS POSSIBLY RELATED TO DEVICE AND CAUSALLY RELATED TO STUDY PROCEDURE. MRI WAS DONE WHICH SHOWED FLUID COLLECTION AND SURGICAL WOUND INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23815944 ↗
• MalfunctionNov 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION OF SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW WOULD NOT THREAD, AND WHEN REMOVED IT WAS DAMAGED WITH SMALL PIECES OF METAL COMING OFF OF IT. 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 23539876 ↗
• MalfunctionNov 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION OF SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW WOULD NOT THREAD, AND WHEN REMOVED IT WAS DAMAGED WITH SMALL PIECES OF METAL COMING OFF OF IT. 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 23539873 ↗
• MalfunctionNov 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION OF SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW WOULD NOT THREAD, AND WHEN REMOVED IT WAS DAMAGED WITH SMALL PIECES OF METAL COMING OFF OF IT. 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 23539868 ↗
• MalfunctionNov 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FOR SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW WOULD NOT THREAD INTO THE SCREW. THE SET SCREW SUSTAINED DAMAGE AND A SMALL FRAGMENT (METAL SHARDS) BROKE OFF, WHICH WAS RECOVERED FROM THE PATIENT. THIS ISSUE OCCURRED AGAIN WITH A SECOND SET SCREW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496040 ↗
• MalfunctionNov 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FOR SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW WOULD NOT THREAD INTO THE SCREW. THE SET SCREW SUSTAINED DAMAGE AND A SMALL FRAGMENT (METAL SHARDS) BROKE OFF, WHICH WAS RECOVERED FROM THE PATIENT. THIS ISSUE OCCURRED AGAIN WITH A SECOND SET SCREW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496032 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL HISTORY: STENOSIS OF LUMBOSACRAL SPINE RELATED DEVICE: DEVICE NAME: CD HORIZON SOLERA 4.75 - SCREW TYPE OF ADDITIONAL SURGERY: REVISION.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain; Spinal Cord Injury; Stenosis

  MAUDE report 23462238 ↗
• MalfunctionSep 17, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CONNECTOR WAS IMPLANTED TO ADD A SECONDARY ROD TO THE CONSTRUCT. WHEN THE SURGEON WENT TO FINAL TIGHTEN IT, THE CONNECTOR SPLAYED, CAUSING THE SET SCREW TO CROSS THREAD AND WOULD NOT SNAP OFF. THEY DISCARDED THE CONNECTOR THAT SPLAYED AND REPLACED IT WITH A DIFFERENT ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073134 ↗
• MalfunctionMay 27, 2025Failure to Align; Failure to Align

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING T 2-S2AI SPINAL DEFORMITY CORRECTION PROCEDURE. IT WAS REPORTED THAT DURING SET SCREW PLACEMENT IN DRMAS SCREW USING ADI TOWER AND FULLY REDUCED ROD, IT WAS NOTICED THAT SET SCREW WAS CROSS THREADING. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085456 ↗
• MalfunctionApr 22, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SET SCREW AND A MAS SCREW HAVING LUMBER FUSION THERAPY FOR LUMBAR STENOSIS. IT WAS REPORTED THAT SCREWS WAS BROKEN AND EXPLANTED IN THE SAME PROCEDURE ON (B)(6) 2023. SET SCREW STRIPPED IN POLYAXIAL SCREW HEAD DURING SET SCREW INSERTION. THERE WAS NO IN-PATIENT HOSPITALIZATION NOR REVISION SURGERY REQUIRED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880988 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINE SURGERY FOR L3/4 STENOSIS WITH RIGHT L3 RADICULOPATHY. IT WAS REPORTED THAT THE SET SCREWS THAT WERE PLACED AT L3 HAD OBSERVABLE METAL STRIPPED OFF THE THREAD WHEN BEING INSERTED. ONE PIECE WAS ASPIRATED INTO THE SURGICAL SUCTION AND ONE PIECE REMAINED ATTACHED TO THE SET SCREW. NO PATIENT SYMPTOMS REPORTED AND NO REVISION SURGERY PERFORMED DUE TO THIS EVENT. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PROCEDURE PERFORMED WAS AN OPEN POSTERIOR L3/4 DECOMPRESSION AND FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879701 ↗
• MalfunctionApr 21, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW COULD NOT BE TURNED INTO THE SCREW. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. THE DOCTOR WANTED TO IMPLANT THE SET SCREW IN THE PATIENT AND IT DID NOT GO INTO THE SCREW HEAD. THE DOCTOR THEN USED A NEW SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870523 ↗
• MalfunctionApr 21, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW COULD NOT BE TURNED INTO THE SCREW. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. THE DOCTOR WANTED TO IMPLANT THE SET SCREW IN THE PATIENT AND IT DID NOT GO INTO THE SCREW HEAD. THE DOCTOR THEN USED A NEW SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870504 ↗
• MalfunctionApr 21, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW COULD NOT BE TURNED INTO THE SCREW. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. THE DOCTOR WANTED TO IMPLANT THE SET SCREW IN THE PATIENT AND IT DID NOT GO INTO THE SCREW HEAD. THE DOCTOR THEN USED A NEW SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870502 ↗
• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A POSTERIOR THORACOLUMBAR FUSION IN A PATIENT. IT WAS REPORTED THAT THE SET SCREW BACKED OFF THE TULIP. A LAMINECTOMY WAS ALSO PERFORMED IN THE THORACIC REGION WHEN THE ILLIAC SCREWS WERE REPLACED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863166 ↗
• MalfunctionMar 20, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING LUMBAR DEGE NERATION SURGERY FOR LUMBAR DEGENERATION. IT WAS REPORTED THAT THE SCREW PLUG WAS DAMAGED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650150 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.