CD HORIZON® Spinal System G7540020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994143181), received between Feb 25, 2019 and Jun 6, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (3 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF. IT WAS REPORTED THAT THE PATIENT PRESENTED POSTOPERATIVE METAL ALLERGY AND THE ADDITIONAL SURGERY WAS PERFORMED FOR THE REMOVAL OF DEVICE ON (B)(6) 2022. THE INITIAL OPERATION WAS PERFORMED AT IWATE MEDICAL UNIVERSITY HOSPITAL ON (B)(6) 2014. THERE WAS NO ALLEGATION ABOUT FAULTY PRODUCTS, BUT THE PATIENT EXPERIENCED METAL ALLERGY SYMPTOMS THAT ARE CONSIDERED DUE TO IMPLANTED PRODUCTS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14600355 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL SAFETY ASSESSES THE REPORTED EVENT OF ¿LUMBAR DISC HERNIATION¿ AT THE ADJACENT LEVEL AS NOT RELATED TO THE DEVICE. THERE WERE NO MALFUNCTIONS WITH THE IMPLANTED PRODUCT. THE DISC HERNIATION OCCURRED AT THE ADJACENT LEVEL.

  Patient problems: Intervertebral Disc Compression or Protrusion; No Clinical Signs, Symptoms or Conditions; Paralysis

  MAUDE report 11567934 ↗
• InjurySep 26, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION (PLF) AT L4-5-S1 DUE TO SYMPTOMS OCCURRED TO L5. POST-OP, SET SCREW LOOSENED. IT WAS ASSUMED THAT THE SET SCREW WAS LOOSENED BEFORE BONE UNION OF POSTERIOR LUMBAR FUSION (PLF) WAS COMPLETED. WHILE USING THE ELECTRIC KNIFE TO PERFORM THE REVISION SURGERY, SPARKS FELL. DUE TO LOOSENING OF THE SET SCREW SEVERE METALLOSIS OCCURED NEAR THE RIGHT SIDE OF S1. PATIENT SUFFERED FROM PSEUDOARTHROSIS AT L5-S1 AND THERE WERE SOME SYMPTOMS AND COMPLICATIONS TO THE LEFT LOWER LIMBS AFTER THIS SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9122134 ↗
• InjuryJul 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L2-S1. ON AN UNKNOWN DATE, POST-OP, A CLEAR ZONE AROUND THE SCREW ON THE RIGHT OF S1 WAS NOTICED AND THE PATIENT EXPERIENCED PAIN IN THE RIGHT LOWER LIMB AND LOWER BACK. HENCE, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019, DURING WHICH THE SET SCREW AT RIGHT OF S1 WAS FOUND LOOSENED, WHICH LED TO A PAIN IN THE LOWER LIMB. THE EXISTING IMPLANT WAS REMOVED AND POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AGAIN AT L5-S1-ILIAC. THE PATIENT'S ISSUE HAS NOW BEEN REPORTED AS RESOLVED.

  Patient problems: Pain

  MAUDE report 8765028 ↗
• InjuryJul 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L2-S1. ON AN UNKNOWN DATE, POST-OP, PATIENT EXPERIENCED PAIN IN THE RIGHT LOWER LIMB AND LOWER BACK. HENCE, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019, DURING WHICH THE SET SCREW AT LEFT OF S1 WAS FOUND LOOSENED. THE EXISTING IMPLANT WAS REMOVED AND POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AGAIN AT L5-S1-ILIAC. THE PATIENT'S ISSUE HAS NOW BEEN REPORTED AS RESOLVED.

  Patient problems: Pain

  MAUDE report 8764957 ↗
• InjuryJul 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L2-S1. ON AN UNKNOWN DATE, POST-OP, PATIENT EXPERIENCED PAIN IN THE RIGHT LOWER LIMB AND LOWER BACK. HENCE, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019, DURING WHICH THE SET SCREW AT LEFT OF L5 WAS FOUND LOOSENED. THE EXISTING IMPLANT WAS REMOVED AND POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AGAIN AT L5-S1-ILIAC. THE PATIENT'S ISSUE HAS NOW BEEN REPORTED AS RESOLVED.

  Patient problems: Pain

  MAUDE report 8764922 ↗
• InjuryFeb 25, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: T10 FRACTURE - THORACIC KYPHOSIS PROCEDURE USED: ARTHRODESIS LEVELS IMPLANTED: T3 - S1 IT WAS REPORTED THAT POST-OP, DUE TO BREAKAGE OF THE CONNECTORS AND RODS THAT PREVENTED FROM FUSION, THE SET SCREW THREAD DAMAGED AND AS A RESULT THE PATIENT SUFFERED WITH PAIN. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8365231 ↗
• InjuryFeb 25, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: T10 FRACTURE - THORACIC KYPHOSIS PROCEDURE USED: ARTHRODESIS LEVELS IMPLANTED: T3 - S1 IT WAS REPORTED THAT POST-OP, DUE TO BREAKAGE OF THE CONNECTORS AND RODS THAT PREVENTED FROM FUSION, THE SET SCREW THREAD DAMAGED AND AS A RESULT THE PATIENT SUFFERED WITH PAIN. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8365217 ↗