CD HORIZON® Spinal System 55840007550Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169004351), received between Sep 11, 2017 and Jan 5, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS A EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956553 ↗
• MalfunctionJan 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/ OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS AN EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956536 ↗
• 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 23816948 ↗
• MalfunctionJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL PROCEDURE DATE: (B)(6) 2025 C2-5 POSTERIOR CERVICAL FUSION WITH C3/4 LAMINECTOMY ADDITIONAL PROCEDURE IS NOT RELATED TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410373 ↗
• InjuryMar 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DEFORMITY CORRECTION. THE PRE-OP DIAGNOSIS WAS AIS. IT WAS REPORTED THAT, DURING POST-OP THE DISTAL IMPLANT(SCREW) WAS SLIDING FROM END OF ROD. SCREW WAS DISLOCATED. PATIENT UNDERWENT REVISION, THE SCREW WAS EXPLANTED AND A NEW SCREW AND SET SCREW WERE IMPLANTED. ONE MONTH LATER THE NEW SCREW THAT WAS REPLACED WAS ALSO FOUND SLIDING OUT FROM THE ROD ON (B)(6) 2023. THERE IS A PLAN TO PERFORM ANOTHER REVISION SURGERY FOR THIS PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535520 ↗
• InjuryOct 19, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: (B)(6). MEDICAL HISTORY (POSITIVE RESPONSE): SURGERY 1: DATE OF SURGERY: (B)(6) 2016. TYPE OF SPINAL SURGERY: DISCECTOMY LEVEL(S): L4/L5 DETAILS: MICRODISCECTOMY. SURGERY 2: DATE OF SURGERY: (B)(6) 2016. TYPE OF SPINAL SURGERY: OTHER LEVEL(S): L4/L5 DETAILS: MEDIAL FACETECTOMY SURGERY 3: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: FORAMINOTOMY LEVEL(S): L4/L5 DETAILS: FORAMINOTOMY FOR RECURRENT HERN IATED DISC SURGERY 4: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: DISCECTOMY LEVEL(S): L4/L5 DETAILS: REVISION OF MICRODISCECTOMY SURGERY 5: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: OTHER LEVEL(S): L4/L5 DETAILS: REVISION OF MEDIAL FACETECTOMY SURGERY 6: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: FORAMINOTOMY LEVEL(S): L4/L5 DETAILS: REVISION. DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: REVISION OF LEFT L5 SCREW. LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: L5/S1 SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: RELATED PLF GRAF

  Patient problems: Pain

  MAUDE report 15630496 ↗
• InjuryDec 22, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT AN OPERA TION FOR RE-SPONDYLOSIS AND DIAGNOSIS OF LUMBAR DISC DEGENERATION AT L4-S1 FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER 3 MONTHS PATIENT HAD BACK PAIN. X-RAY SHOWED THAT BOTH S1 SCREWS WERE BROKEN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: Pain

  MAUDE report 13058289 ↗
• InjuryNov 2, 2020Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED OF L1-L5 POSTERIOR APPROACH PATIENT PRONE PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD A REACTION POTENTIALLY ALLERGIC REACTION TO THE COBALT CHROME (CHROMALOY) CONSTRUCT OF SOLERA 5.5/6.0. THERE WAS METAL DEBRIS IS SOFT TISSUE AND MUSCLE THAT WAS VISIBLE AFTER INCISION. REVISION SURGERY WAS PERFORMED AND REPLACED ALL SCREWS WITH LEGACY TITANIUM AND EXTENDED THE CONSTRUCT. A PREVIOUS METAL ALLERGY WAS NOT DOCUMENTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 10768666 ↗
• MalfunctionJun 19, 2020Break; Break

  THE REASON FOR THE REVISION HAD NO RELATION WITH THE BROKEN SCREW. THE SPECIFIC REASON FOR PERFORMING THE REVISION SURGERY IS NOT KNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173824 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-S1 FUSION AND DECOMPRESSION DUE TO SPINAL STENOSIS, CONGENITAL SPINE DEFORMITY AND SPONDYLOLISTHESIS. THE ALLEGED SCREW WAS IMPLANTED IN THIS SURGERY. DECOMPRESSION WAS DONE FIRST, PEDICLE MARKERS WERE USED TO DETERMINE SCREW PLACEMENT VIA X-RAY. PEDICLES WERE MEASURED AND SCREWS WERE PLACED. SCREWS LOOKED GOOD ON FINAL X-RAY BEFORE CLOSING. A CROSSLINK WAS ALSO USED BETWEEN L4 AND L5 LEVELS. ON AN UNKNOWN DATE, POST-OP, S1 SCREWS WERE FOUND TO BE BROKEN BILATERALLY. THIS PROBLEM WAS DISCOVERED DURING PATIENT FOLLOW UP VISIT SOMEWHERE BETWEEN 3 MONTHS AND 6 MONTHS AFTER THE SURGERY. NO FALL OR OTHER TRAUMATIC EVENT WAS REPORTED WHICH COULD HAVE CAUSED THE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT. THE BROKEN SCREWS ARE STILL IMPLANTED IN THE PATIENT; AND THE PATIENT DOES NOT WISH TO HAVE ANOTHER SURGERY TO REMOVE THE BROKEN HARDWARE. A CT HAS BEEN ORDERED TO SEE IF THE PATIENT HAS ACQUIRED A SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415544 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-S1 FUSION AND DECOMPRESSION DUE TO SPINAL STENOSIS, CONGENITAL SPINE DEFORMITY AND SPONDYLOLISTHESIS. THE ALLEGED SCREW WAS IMPLANTED IN THIS SURGERY. DECOMPRESSION WAS DONE FIRST, PEDICLE MARKERS WERE USED TO DETERMINE SCREW PLACEMENT VIA X-RAY. PEDICLES WERE MEASURED AND SCREWS WERE PLACED. SCREWS LOOKED GOOD ON FINAL X-RAY BEFORE CLOSING. A CROS SLINK WAS ALSO USED BETWEEN L4 AND L5 LEVELS. ON AN UNKNOWN DATE, POST-OP, S1 SCREWS WERE FOUND TO BE BROKEN BILATERALLY. THIS PROBLEM WAS DISCOVERED DURING PATIENT FOLLOW UP VISIT SOMEWHERE BETWEEN 3 MONTHS AND 6 MONTHS AFTER THE SURGERY. NO FALL OR OTHER TRAUMATIC EVENT WAS REPORTED WHICH COULD HAVE CAUSED THE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT. THE BROKEN SCREWS ARE STILL IMPLANTED IN THE PATIENT; AND THE PATIENT DOES NOT WISH TO HAVE ANOTHER SURGERY TO REMOVE THE BROKEN HARDWARE. A CT HAS BEEN ORDERED TO SEE IF THE PATIENT HAS ACQUIRED A SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415524 ↗
• InjuryJan 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS WITH NEUROGENIC CLAUDICATION FUSION OF LUMBAR SPINE AND UNDERWENT POSTERIOR FUSION AT L1-S1. POST-OP, PEDICLE SCREW BROKE NEAR TIPS OR DISTAL ENDS. FRAGMENTS REMAINING IN THE PATIENT IS REPORTED TO BE UNKNOWN. REMOVAL HARDWARE EXTENSION POSTERIOR FUSION TO ILIUM WAS PERFORMED AS THE RESULT OF THE EVENT. PATIENT COMPLICATION REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207356 ↗
• InjuryJan 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS WITH NEUROGENIC CLAUDICATION FUSION OF LUMBAR SPINE AND UNDERWENT POSTERIOR FUSION AT L1-S1. POST-OP, PEDICLE SCREW BROKE NEAR TIPS OR DISTAL ENDS. FRAGMENTS REMAINING IN THE PATIENT IS REPORTED TO BE UNKNOWN.REMOVAL HARDWARE EXTENSION POSTERIOR FUSION TO ILIUM WAS PERFORMED AS THE RESULT OF THE EVENT. PATIENT COMPLICATION REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207355 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2017 IN WHICH SCREWS HAS BEEN IMPLANTED ON L5-S1. POST-OP, THE PATIENT COMPLAINED OF RADICULOPATHY AND LEG PAIN. THE SURGEON STATED THAT THIS MAY BE DUE TO ALL POLYAXIAL SCREWS. ALSO, SURGEON WAS USING NEURO MONITORING THROUGHOUT THE ENTIRE CASE AND THERE WERE NO EVENTS DURING THE CASE, INCLUDING THE TIME OF IMPLANTING THE SCREWS AND OTHER IMPLANTS AND EVEN AFTER THE SCREWS WERE PLACED AND THEY DID THE FINAL MONITORING. POST-OP IMAGES SHOWED THAT THE SCREWS ARE PLACED STRAIGHT DOWN THE PEDICLE WITHOUT ANY BREACHING OF WALLS OF THE VERTEBRAL BODY AND ARE IN A GOOD POSITION.

  Patient problems: Neuropathy; Pain

  MAUDE report 6854338 ↗

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.