CD HORIZON® SOLERA® Spinal System 54850017545Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169491649), received between Jun 20, 2018 and Dec 26, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionDec 26, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN L4/5 SPINAL FUSION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE CUSTOMER HAD THE MAS SCREW IMPLANTED AND WAS SUBSEQUENTLY UNABLE TO SECURE THE SET SCREWS TO THE ROD. THIS WAS DUE TO A DEFECT IN THE THREAD OF THE PEDICLE SCREW. 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 23894871 ↗
• InjuryMar 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN MINIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) AT L5-S1 FOR REVISION L5-S1 POSTERIOR LUMBAR FUSION/MODIFICATION OF HARDWARE. IT WAS REPORTED THAT THE PATIENT HAD POSTERIOR THIGH/LEG PAIN WITH LEFT FORAMINAL STENOSIS AND THE PLAN FOR THE PROCEDURE WAS TO REMOVE THE LEFT SIDED SET SCREWS AND RODS, RE-EVALUATE THE DECOMPRESSION AND CONFIRM THAT THE LEFT SCREWS WERE NOT LOOSE AND CONFIRM THAT THE CAGE HAD NOT MIGRATED POSTERIORLY. THE SET SCREWS WERE REMOVED SUCCESSFULLY. WHEN THE SURGEON WENT TO REMOVE THE ROD, THE TULIP OF THE S1 SCREW WAS DISCOVERED BROKEN FROM THE SHAFT OF THE SCREW. THE SURGEON RE-EVALUATED THE RIGHT SIDED HARDWARE AND DISCOVERED THE SAME SITUATION. THE INTERBODY WAS EVALUATED AND HAD SHIFTED POSTERIORLY. THE SURGEON USED A TAMP AND INSERTED THE CAGE FORWARD. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH CAGE, RODS AND SET SCREWS.

  Patient problems: Pain

  MAUDE report 18854112 ↗
• InjuryMar 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN M INIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) AT L5-S1 FOR REVISION L5-S1 POSTERIOR LUMBAR FUSION/MODIFICATION OF HARDWARE. IT WAS REPORTED THAT THE PATIENT HAD POSTERIOR THIGH/LEG PAIN WITH LEFT FORAMINAL STENOSIS AND THE PLAN FOR THE PROCEDURE WAS TO REMOVE THE LEFT SIDED SET SCREWS AND RODS, RE-EVALUATE THE DECOMPRESSION AND CONFIRM THAT THE LEFT SCREWS WERE NOT LOOSE AND CONFIRM THAT THE CAGE HAD NOT MIGRATED POSTERIORLY. THE SET SCREWS WERE REMOVED SUCCESSFULLY. WHEN THE SURGEON WENT TO REMOVE THE ROD, THE TULIP OF THE S1 SCREW WAS DISCOVERED BROKEN FROM THE SHAFT OF THE SCREW. THE SURGEON RE-EVALUATED THE RIGHT SIDED HARDWARE AND DISCOVERED THE SAME SITUATION. THE INTERBODY WAS EVALUATED AND HAD SHIFTED POSTERIORLY. THE SURGEON USED A TAMP AND INSERTED THE CAGE FORWARD. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH CAGE, RODS AND SET SCREWS.

  Patient problems: Pain

  MAUDE report 18854111 ↗
• InjuryFeb 24, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE, KYPHOSIS. IT WAS REPORTED THAT POST-OP, THERE WAS REPORT OF METALLOSIS FOR ALL SCREWS AND LEFT ROD WAS BROKEN. ALSO FOR SET SCREW THERE WAS LOOSENING OF SET SCREW/SCREW INTERFACE. PRODUCTS WERE EXPLANTED. PATIENT ACHIEVED SOLID FUSION. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. EVENT DATE IS UNKNOWN, IT IS BETWEEN IMPLANT DATE AND REMOVAL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371304 ↗
• InjuryFeb 24, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE, KYPHOSIS. IT WAS REPORTED THAT POST-OP, THERE WAS REPORT OF METALLOSIS FOR ALL SCREWS AND LEFT ROD WAS BROKEN. ALSO FOR SET SCREW THERE WAS LOOSENING OF SET SCREW/SCREW INTERFACE. PRODUCTS WERE EXPLANTED. PATIENT ACHIEVED SOLID FUSION. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. EVENT DATE IS UNKNOWN, IT IS BETWEEN IMPLANT DATE AND REMOVAL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371286 ↗
• MalfunctionMar 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH T8 FRACTURE; AND UNDERWENT T6-T11 FUSION. INTRA-OP, T11 LEFT SCREW PULLED OUT OF THE VERTEBRAL BODY WHEN THE SURGEON WAS TIGHTENING THE SET SCREW. THE SURGEON LEFT THE SCREW OUT ON THAT SIDE. THE SCREW WAS EXPLANTED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9879185 ↗
• InjuryJun 20, 2018Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT PRESENTED TO SURGEON WITH PAIN. BONE SCAN COMPLETED AND SHOWED HOT SPOTS AT L3 AND S1. SURGEON DECIDED TO REOPERATE AND REPLACE THE SCREW IN REVISION SURGERY. DURING REMOVAL, SURGEON NOTICED A LARGE AMOUNT OF METALLOSIS ON THE LEFT L3 LEVEL.

  Patient problems: Pain

  MAUDE report 7618085 ↗
• InjuryJun 20, 2018Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT PRESENTED TO SURGEON WITH PAIN. BONE SCAN COMPLETED AND SHOWED HOT SPOTS AT L3 AND S1. SURGEON DECIDED TO REOPERATE AND REPLACE THE SCREW IN REVISION SURGERY. DURING REMOVAL, SURGEON NOTICED A LARGE AMOUNT OF METALLOSIS ON THE LEFT L3 LEVEL.

  Patient problems: Pain

  MAUDE report 7618083 ↗