CD HORIZON ESSENCE™ Spinal System 4540020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169428898), received between Mar 7, 2018 and May 10, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2022Break; Break

  THE INFORMATION RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR ARTHRODESIS FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT COMPLAINING OF PAIN 3 MONTH AFTER THE SURGERY, FROM THE X-RAY EXAMINATION IT WAS FOUND THAT IMPLANTED SCREWS WAS BROKEN. ONCE THE SECOND SURGERY WAS SCHEDULED, IT WAS EVIDENT THAT DUE TO THE POSITION OF THE BROKEN SCREW, IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THIS IMPLANT AND, THEREFORE, IT WAS NOT REPLACED. THERE WAS FRAGMENT OF IMPLANT REMAINING IN THE PATIENT. THERE WAS NO FURTHER INFORMATION REPORTED. PATIENT MEDICAL HISTORY- SMOKING USE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 14344076 ↗
• InjuryMay 10, 2022Break; Break

  THE INFORMATION RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR ARTHRODESIS FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT COMPLAINING OF PAIN 3 MONTH AFTER THE SURGERY, FROM THE X-RAY EXAMINATION IT WAS FOUND THAT IMPLANTED SCREWS WAS BROKEN. ONCE THE SECOND SURGERY WAS SCHEDULED, IT WAS EVIDENT THAT DUE TO THE POSITION OF THE BROKEN SCREW, IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THIS IMPLANT AND, THEREFORE, IT WAS NOT REPLACED. THERE WAS FRAGMENT OF IMPLANT REMAINING IN THE PATIENT. THERE WAS NO FURTHER INFORMATION REPORTED. PATIENT MEDICAL HISTORY - SMOKING USE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 14344053 ↗
• InjuryMay 10, 2022Break; Break

  THE INFORMATION RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR ARTHRODESIS FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT COMPLAINING OF PAIN 3 MONTH AFTER THE SURGERY, FROM THE X-RAY EXAMINATION IT WAS FOUND THAT IMPLANTED SCREWS WAS BROKEN. ONCE THE SECOND SURGERY WAS SCHEDULED, IT WAS EVIDENT THAT DUE TO THE POSITION OF THE BROKEN SCREW, IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THIS IMPLANT AND, THEREFORE, IT WAS NOT REPLACED. THERE WAS FRAGMENT OF IMPLANT REMAINING IN THE PATIENT. THERE WAS NO FURTHER INFORMATION REPORTED. PATIENT MEDICAL HISTORY - SMOKING USE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 14344039 ↗
• InjuryMar 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE X-RAY IMAGE PROVIDED SHOWED BREAK-OFF SET SCREW OUT OF THE HEAD OF THE SCREW WHICH CAUSED NERVE ROOT COMPRESSION IN TWO LEVELS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX AND REPLACE THE THREE FAILED SCREWS, TWO RODS AND TEN SET SCREWS. PATIENT HAD LOWER LIMB WEAKNESS AND NO DISABILITY.

  Patient problems: Undesired Nerve Stimulation; Weakness

  MAUDE report 7321644 ↗
• InjuryMar 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE X-RAY IMAGE PROVIDED SHOWED BREAK-OFF SET SCREW OUT OF THE HEAD OF THE SCREW WHICH CAUSED NERVE ROOT COMPRESSION IN TWO LEVELS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX AND REPLACE THE THREE FAILED SCREWS, TWO RODS AND TEN SET SCREWS. PATIENT HAD LOWER LIMB WEAKNESS AND NO DISABILITY .

  Patient problems: Undesired Nerve Stimulation; Weakness

  MAUDE report 7321643 ↗
• InjuryMar 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE X-RAY IMAGE PROVIDED SHOWED BREAK-OFF SET SCREW OUT OF THE HEAD OF THE SCREW WHICH CAUSED NERVE ROOT COMPRESSION IN TWO LEVELS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX AND REPLACE THE THREE FAILED SCREWS, TWO RODS AND TEN SET SCREWS. PATIENT HAD LOWER LIMB WEAKNESS AND NO DISABILITY.

  Patient problems: Undesired Nerve Stimulation; Weakness

  MAUDE report 7321638 ↗