CD HORIZON® Spinal System 55840005550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994972019), received between Apr 6, 2018 and Jul 28, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Clinical Study) regarding a patient with clinical ID (b)(6), study name (b)(6). It was reported that patient had worsening back pain. Persistent numbness and pain following spinal fusion surgery, with symptoms suggesting nerve irritation. Imaging shows minimal graft maturation in the posterior spinal fusion from L4 to S1, which may contribute to symptoms. Possible irritation from bone fragments or screw placement affecting L4 and L5 nerve roots. X-ray was performed on (b)(6) 2025, Imaging shows minimal graft maturation in the posterior spinal fusion from L4 to S1, which may contribute to symptoms. Possible irritation from bone fragments or screw placement affecting L4 and L5 nerve roots. AE resulted in External Bone Growth Stimulator treatment. Investigator assessment: Causal relationship to study procedure and probable related to a Medtronic CST device. Sponsor assessment is same as investigator. Outcome of this AE is recovering/resolving. Additional information received. Diagnostic test: xray, on (b)(6) 2025: diagnostic test result: imaging shows minimal graft maturation in the poste

  Patient problems: Back pain; Numbness

  MAUDE report 50057759 ↗
• MalfunctionAug 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: INSTABILITY (UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS) PROCEDURE PERFORMED: POSTERIOR LUMBAR FUSION (PLF) WITH L5/S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L2/L3; L3/L4; L4/L5; L5/S1 EVENT DATE: (B)(6) 2020 & (B)(6) 2020 POST OP, MEDICAL IMAGE REVIEW SHOWED THAT NO GRAFT AT L3-L4,L4-L5. SUP/INF LUCENT LINES NOT SEEN WITH THIS GRAFT TYPE; RIGHT/LEFT INTERBODY BONE OBSCURED BY OVERLYING BONE; S1 SCREWS BOTH LOOSE AND UPPER SACRAL FRAGMENTATION; ADJUDICATED. BOTH S1 SCREWS WITH EVIDENCE OF LOOSENING. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10423959 ↗
• MalfunctionAug 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: INSTABILITY (UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS) PROCEDURE PERFORMED: POSTERIOR LUMBAR FUSION (PLF) WITH L5/S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L2/L3; L3/L4; L4/L5; L5/S1 EVENT DATE: (B)(6) 2020 <(>&<)> (B)(6) 2020 POST OP, MEDICAL IMAGE REVIEW SHOWED THAT NO GRAFT AT L3-L4,L4-L5. SUP/INF LUCENT LINES NOT SEEN WITH THIS GRAFT TYPE; RIGHT/LEFT INTERBODY BONE OBSCURED BY OVERLYING BONE; S1 SCREWS BOTH LOOSE AND UPPER SACRAL FRAGMENTATION; ADJUDICATED. BOTH S1 SCREWS WITH EVIDENCE OF LOOSENING. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10423952 ↗
• MalfunctionAug 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: INSTABILITY (UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS) PROCEDURE PERFORMED: POSTERIOR LUMBAR FUSION (PLF) WITH L5/S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L2/L3; L3/L4; L4/L5; L5/S1 EVENT DATE: (B)(6) 2020 POST OP, MEDICAL IMAGE REVIEW SHOWED THAT NO GRAFT AT L3-L4,L4-L5. SUP/INF LUCENT LINES NOT SEEN WITH THIS GRAFT TYPE; RIGHT/LEFT INTERBODY BONE OBSCURED BY OVERLYING BONE; S1 SCREWS BOTH LOOSE AND UPPER SACRAL FRAGMENTATION; ADJUDICATED. BOTH S1 SCREWS WITH EVIDENCE OF LOOSENING. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10423935 ↗
• InjuryApr 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRE-OPERATIVELY HAD LUMBAR BACK PAIN AND UNDERWENT LUMBAR POSTERIOR FIXATION AT L3/4/5. POST-OP, THE SCREWS AT L5 WERE BROKEN. FRAGMENTS OF THE BROKEN PART REMAINED IN THE PATIENT. BACK PAIN WAS REPORTED AS THE RESULT OF THE EVENT. A PRIMARY SURGERY WAS PERFORMED DUE TO THE EVENT.

  Patient problems: Pain

  MAUDE report 7404857 ↗
• InjuryApr 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRE-OPERATIVELY HAD LUMBAR BACK PAIN AND UNDERWENT LUMBAR POSTERIOR FIXATION AT L3/4/5. POST-OP, THE SCREWS AT L5 WERE BROKEN. FRAGMENTS OF THE BROKEN PART REMAINED IN THE PATIENT. BACK PAIN WAS REPORTED AS THE RESULT OF THE EVENT. A PRIMARY SURGERY WAS PERFORMED DUE TO THE EVENT.

  Patient problems: Pain

  MAUDE report 7404835 ↗

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.