CD HORIZON® Spinal System 55840008580Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169004474), received between Jan 3, 2017 and Dec 16, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 23817058 ↗
• MalfunctionJul 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A D 12-S2 ILLIUM FIXATION IN A PATIENT. IT WAS REPORTED THAT THE LEFT ROD BROKE AND SCREW BROKE. THE ROD AND SCREW REMAINS IMPLANTED AND CURRENTLY NO REVISION SURGERY PLANNED. PATIENT IS HAVING PERSISTENT PAIN IN HER HIPS REQUIRING ANALGESICS ON A REGULAR BASIS. PATIENT GETS INTERMITTENT SI JOINT BLOCKS.

  Patient problems: Pain

  MAUDE report 19710291 ↗
• MalfunctionFeb 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PROCEDURE D12-S2 FIXATION. IT WAS REPORTED THAT THE RIGHT ILIAC SCREW WAS BROKEN. FRAGMENTS LEFT INSIDE THE PATIENT. PATIENT IS HAVING PERSISTENT PAIN IN HIPS REQUIRING ANALGESICS ON A REGULAR BASIS. REVISION SURGERY IS NOT PLANNED. PATIENT GOT INTERMITTENT SI JOINT BLOCKS.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 18647857 ↗
• InjuryJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN ILIAC SPINE PROCEDURE IN A PATIENT DIAGNOSED WITH SCOLIOSIS. IT WAS REPORTED THAT THE CAP CAME OFF THE SCREW HEAD. 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 15119105 ↗
• InjuryJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN ILIAC SPINE PROCEDURE IN A PATIENT DIAGNOSED WITH SCOLIOSIS. IT WAS REPORTED THAT THE CAP CAME OFF THE SCREW HEAD. 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 15119101 ↗
• InjuryMar 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT FUSION AT T11-ILIUM. POST-OP, ON (B)(6) 2019, THE PATIENT PRESENTED WITH ACUTE PAIN AND INFECTION; HENCE, THE WOUND WAS CLEANED AS THE PATIENT GOT KLEBSIELLA. NO IMPLANT OR INSTRUMENTATION WAS REMOVED IN THIS SURGERY. LATER, THE PATIENT AGAIN PRESENTED WITH PAIN; AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019. ALLEGEDLY, THE TULIP OF THE REPORTED SCREW WAS FOUND LOCKED AT AN ANGLE. IN THIS REVISION SURGERY, ALL THE IMPLANTS WERE REMOVED AND CHANGED AS THE PATIENT HAD ENTEROCOCCUS; AND THE FUSION WAS EXTENDED FROM T11-ILIUM TO T11-S2.

  Patient problems: Unspecified Infection

  MAUDE report 9794693 ↗
• InjuryMar 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT FUSION AT T11-ILIUM. POST-OP, ON (B)(6) 2019, THE PATIENT PRESENTED WITH ACUTE PAIN AND INFECTION; HENCE, THE WOUND WAS CLEANED AS THE PATIENT GOT KLEBSIELLA. NO IMPLANT OR INSTRUMENTATION WAS REMOVED IN THIS SURGERY. LATER, THE PATIENT AGAIN PRESENTED WITH PAIN; AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019. ALLEGEDLY, THE TULIP OF THE REPORTED SCREW WAS FOUND LOCKED AT AN ANGLE. IN THIS REVISION SURGERY, ALL THE IMPLANTS WERE REMOVED AND CHANGED AS THE PATIENT HAD ENTEROCOCCUS; AND THE FUSION WAS EXTENDED FROM T11-ILIUM TO T11-S2.

  Patient problems: Unspecified Infection

  MAUDE report 9794610 ↗
• MalfunctionFeb 8, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: BACK PAIN PROCEDURE: POSTERIOR SPINAL FUSION T-10 TO PELVIS LEVELS IMPLANTED: 7 LEVEL IT WAS REPORTED THAT POST-OP, SCREW WAS BROKEN AND WAS IMPLANTED IN THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8321000 ↗
• InjuryJun 2, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH ADULT DEGENERATIVE DISEASE AND SCOLIOSIS UNDERWENT SPINAL SURGERY FROM T10 - PELVIS. POST-OP PELVIC SCREWS BREAKAGE (BILATERALLY) AT SACRO-ILIAC JOINT WAS OBSERVED CAUSING PAIN TO THE PATIENT. IT IS NOT CONFIRMED WHETHER SURGEON WILL PERFORM REVISION SURGERY ON THE PATIENT.

  Patient problems: Pain

  MAUDE report 6607192 ↗
• InjuryJun 2, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH ADULT DEGENERATIVE DISEASE AND SCOLIOSIS UNDERWENT SPINAL SURGERY FROM T10 - PELVIS. POST-OP PELVIC SCREWS BREAKAGE (BILATERALLY) AT SACRO-ILIAC JOINT WAS OBSERVED CAUSING PAIN TO THE PATIENT. IT IS NOT CONFIRMED WHETHER SURGEON WILL PERFORM REVISION SURGERY ON THE PATIENT.

  Patient problems: Pain

  MAUDE report 6607185 ↗
• InjuryApr 7, 2017Break; Break

  PRE-OP DIAGNOSIS: ADULT DEGENERATIVE DISEASE AND SCOLIOSIS LEVELS IMPLANTED: T10-PELVIS IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PELVIC SCREWS SHEARED OFF. DUE TO WHICH PATIENT HAD PAIN ASSOCIATED WITH MOVEMENT.

  Patient problems: Pain

  MAUDE report 6471114 ↗
• InjuryApr 7, 2017Break; Break

  PRE-OP DIAGNOSIS: ADULT DEGENERATIVE DISEASE AND SCOLIOSIS LEVELS IMPLANTED: T10-PELVIS IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PELVIC SCREWS SHEARED OFF. DUE TO WHICH PATIENT HAD PAIN ASSOCIATED WITH MOVEMENT.

  Patient problems: Pain

  MAUDE report 6471113 ↗
• MalfunctionJan 3, 2017Break; Break

  PRE-OP DIAGNOSIS: ADULT DEGENERATIVE SCOLIOSIS LEVELS IMPLANTED :T10- PELVIS IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY. POST-OP, PELVIC SCREW SHEERED OFF UNDER THE HEAD OF THE SCREW. FRAGMENTS OF THE IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6220771 ↗

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.