CD HORIZON® Spinal System 7540020Recalls & reported problems

Summary

The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 00885074457093), received between Nov 15, 2016 and Sep 22, 2026 — classified as 32 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (90 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 257 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Product Quality Problem; Material Deformation

  Information was received from multiple sources (Manufacturer Representative, Distributor) regarding a device used in a Spinal therap y. It was reported that the set screw was received in damaged condition from the warehouse prior to supply to a hospital. There was no patient involvement in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850867 ↗
• MalfunctionSep 17, 2026Material Deformation

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Distributor) regarding a patient h aving Transforaminal Lumbar Interbody Fusion due to Degenerative Disc Disease. It was reported that set screw thread was stripped during screw tightening and could not be used for the patient.. There were no patient symptoms reported. There were no further complic ations reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797847 ↗
• MalfunctionApr 28, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A BREAK OFF SET SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO IMPLANT, MULTIPLE BREAK OFF SET SCREW UNITS HAD ATTACHED TO THE KEY, MAKING IT IMPOSSIBLE TO BREAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015276 ↗
• MalfunctionApr 27, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A BREAK OFF SET SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO IMPLANT, MULTIPLE BREAK OFF SET SCREW UNITS HAD ATTACHED TO THE KEY, MAKING IT IMPOSSIBLE TO BREAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996880 ↗
• MalfunctionApr 24, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A BREAK OFF SET SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO IMPLANT, MULTIPLE BREAK OFF SET SCREW UNITS HAD ATTACHED TO THE KEY, MAKING IT IMPOSSIBLE TO BREAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981815 ↗
• MalfunctionApr 23, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A BREAK OFF SET SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO IMPLANT, MULTIPLE BREAK OFF SET SCREW UNITS HAD ATTACHED TO THE KEY, MAKING IT IMPOSSIBLE TO BREAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24963773 ↗
• MalfunctionApr 21, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A BREAK OFF SET SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO IMPLANT, MULTIPLE BREAK OFF SET SCREW UNITS HAD ATTACHED TO THE KEY, MAKING IT IMPOSSIBLE TO BREAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935466 ↗
• MalfunctionFeb 8, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A TLIF PROCEDURE WITH PEDICLE SCREW PLACEMENT AT LEVELS L2-L5 FOR A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF LUMBOSACRAL PLEXOPATHY, THE SET SCREW BROKE BEFORE FINAL TIGHTENING. A NEW SET SCREW WAS USED TO SECURE THE CONSTRUCT AND COMPLETE THE SURGERY. NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINED IN THE PATIENT. THE PRODUCT WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288215 ↗
• MalfunctionFeb 4, 2026Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2 - L5 PEDICLE SCREW PLACEMENT, TLIF IN A PATIENT DIAGNOSED WITH LUMBOSACRAL PLEXOPATHY. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE FINAL TIGHTENING DUE TO WHICH ANOTHER SET SCREW WAS USED TO SECURE THE ROD AND COMPLETE THE SURGERY. EVENT OCCURRED DUE TO DEFECTIVE PRODUCT. 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 24256786 ↗
• MalfunctionFeb 2, 2026Device Slipped

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING P ROCEDURE OF REMOVAL OF THE TUMOR AND FIXATION OF THE IMPLANT IN A PATIENT DIAGNOSED WITH CERVICAL AND THORACIC SPINE TUMORS. IT WAS REPORTED THAT DURING A NORMAL SURGICAL PROCEDURE, WHEN TIGHTENING THE SET SCREW, THE SET SCREW AND SCREW SLIPPED, INDICATING THAT THE SET SCREW OCCURRED SLIPPERY THREAD. 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 24229679 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE FOR THORACOLUMBAR SCOLIOSIS. IT WAS REPORTED THAT DIFFICULTIES AROSE WHILE INSERTING THE RODS DUE TO THE SEVERITY OF THE SCOLIOSIS. THREAD DAMAGE (STRIPPED THREADS) OCCURRED IN LOCKING SCREWS, WHICH WERE SUBSEQUENTLY DEEMED UNUSABLE AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED EVENT OCCURRED DURING NORMAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713662 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE FOR THORACOLUMBAR SCOLIOSIS. IT WAS REPORTED THAT DIFFICULTIES AROSE WHILE INSERTING THE RODS DUE TO THE SEVERITY OF THE SCOLIOSIS. THREAD DAMAGE (STRIPPED THREADS) OCCURRED IN LOCKING SCREWS, WHICH WERE SUBSEQUENTLY DEEMED UNUSABLE AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED EVENT OCCURRED DURING NORMAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713653 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE FOR THORACOLUMBAR SCOLIOSIS. IT WAS REPORTED THAT DIFFICULTIES AROSE WHILE INSERTING THE RODS DUE TO THE SEVERITY OF THE SCOLIOSIS. THREAD DAMAGE (STRIPPED THREADS) OCCURRED IN LOCKING SCREWS, WHICH WERE SUBSEQUENTLY DEEMED UNUSABLE AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED EVENT OCCURRED DURING NORMAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713647 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE FOR THORACOLUMBAR SCOLIOSIS. IT WAS REPORTED THAT DIFFICULTIES AROSE WHILE INSERTING THE RODS DUE TO THE SEVERITY OF THE SCOLIOSIS. THREAD DAMAGE (STRIPPED THREADS) OCCURRED IN LOCKING SCREWS, WHICH WERE SUBSEQUENTLY DEEMED UNUSABLE AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED EVENTOCCURRED DURING NORMAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713620 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE FOR THORACOLUMBAR SCOLIOSIS. IT WAS REPORTED THAT DIFFICULTIES AROSE WHILE INSERTING THE RODS DUE TO THE SEVERITY OF THE SCOLIOSIS. THREAD DAMAGE (STRIPPED THREADS) OCCURRED IN LOCKING SCREWS, WHICH WERE SUBSEQUENTLY DEEMED UNUSABLE AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED EVENT OCCURRED DURING NORMAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713615 ↗
• MalfunctionDec 3, 2025Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR SPINE THERAPY. IT WAS REPORTED THAT THE CLINICIAN HAD A THREAD SLIP WHEN SCREWING THE PEDICLE SCREW INTO THE SET SCREW, WHICH MADE IT IMPOSSIBLE TO SCREW IT IN. LATER, TWO NEW SET SCREWS WERE REPLACED DURING THE OPERATION.. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702973 ↗
• MalfunctionDec 2, 2025Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR SPINE THERAPY. IT WAS REPORTED THAT THE CLINICIAN HAD A THREAD SLIP WHEN SCREWING THE PEDICLE SCREW INTO THE SET SCREW, WHICH MADE IT IMPOSSIBLE TO SCREW IT IN. LATER, TWO NEW SET SCREWS WERE REPLACED DURING THE OPERATION.. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692968 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWS WERE LOOSE AND THERE WAS LOOSENING OF THE STRUCTURE. THE PATIENT WENT REVISION SURGERY ON (B)(6) 2025 AS A RESULT OF THE EVENT AND SCREWS WERE EXPLANTED TO INSERT SOLERA 5.5/6.0 IMPLANT. 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 22847255 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWS WERE LOOSE AND THERE WAS LOOSENING OF THE STRUCTURE. THE PATIENT WENT REVISION SURGERY ON (B)(6) 2025 AS A RESULT OF THE EVENT AND SCREWS WERE EXPLANTED TO INSERT SOLERA 5.5/6.0 IMPLANT. 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 22847247 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWS WERE LOOSE AND THERE WAS LOOSENING OF THE STRUCTURE. THE PATIENT WENT REVISION SURGERY ON (B)(6) 2025 AS A RESULT OF THE EVENT AND SCREWS WERE EXPLANTED TO INSERT SOLERA 5.5/6.0 IMPLANT. 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 22847243 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWS WERE LOOSE AND THERE WAS LOOSENING OF THE STRUCTURE. THE PATIENT WENT REVISION SURGERY ON (B)(6) 2025 AS A RESULT OF THE EVENT AND SCREWS WERE EXPLANTED TO INSERT SOLERA 5.5/6.0 IMPLANT. 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 22847230 ↗
• MalfunctionAug 5, 2025Defective Device; Defective Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR OPEN THORACOLUMBAR SPINE PROCEDURE, POSTERIOR OPEN DIRECT DECOMPRESSION FOR LUMBAR POSTERIOR DISC HERNIATION. IT WAS REPORTED THAT WHEN SCREWING THE SET SCREW DURING THE OPERATION, THERE WAS AN OBVIOUS DEFECT IN THE PRODUCT THREAD AND THE SET SCREW COULD NOT BE SCREWED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710899 ↗
• MalfunctionAug 5, 2025Defective Device; Defective Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR OPEN THORACOLUMBAR SPINE PROCEDURE, POSTERIOR OPEN DIRECT DECOMPRESSION FOR LUMBAR POSTERIOR DISC HERNIATION. IT WAS REPORTED THAT WHEN SCREWING THE SET SCREW DURING THE OPERATION, THERE WAS AN OBVIOUS DEFECT IN THE PRODUCT THREAD AND THE SET SCREW COULD NOT BE SCREWED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710872 ↗
• MalfunctionApr 22, 2025Device Slipped; Material Deformation; Device Slipped; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR SPINE DEGENERATION. PROCEDURE OR TECHNIQUE USED WAS PLIF (POSTERIOR LUMBAR). PATIENT HAD A MEDICAL HISTORY OF SMOKING. IT WAS REPORTED THAT DURING THE IMPLANTATION PROCESS OF THE SET SCREW, OCCURRED DEFORMATION SLIPPERY THREAD, SO THAT THE LOCKING COULD NOT BE COMPLETED, AND THE IMPLANTATION PROCESS WAS LIMITED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880474 ↗
• MalfunctionMar 15, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN POSTERIOR LUMBAR INTERBODY FUSION SPINAL CANAL DECOMPRESSION SITE FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT DURING THE IMPLANTATION PROCESS OF THE SET SCREW, THE THREAD WAS SLIPPERY DUE TO DEFORMATION AND THE LOCKING COULD NOT BE COMPLETED, SO THE IMPLANTATION PROCESS WAS LIMITED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613315 ↗