CD HORIZON® Spinal System 7440020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885074488639), received between Apr 26, 2018 and Jan 31, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2022Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR LUMBAR SPINE SURGERY, ANTERIOR LUMBAR SPINE COMBINED WITH LESIONS, ANTERIOR DEBRIDEMENT, SCREW ROD FIXATION FOR LUMBAR 4 VERTEBRAL TUBERCULOSIS. IT WAS REPORTED THAT THE DEVICES HAD BEEN IMPLANTED IN THE BODY, AND WERE REMOVED AFTER THE SCREWS WERE DISLODGED. INTRAOPERATIVELY, THE SCREWS SLIPPED AND DISENGAGED. 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 13392029 ↗
• MalfunctionJan 12, 2021Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF L1 CONE FRACTURE IN NEED OF ANTERIOR L1 CONE RESECTION, FRACTURE REDUCTION, SPINAL CANAL DECOMPRESSION AND INTERNAL FIXATION USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW SLIPPED AND COULDN'T BE FIXED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO DELAY IN PROCEDURE TIME REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153141 ↗
• MalfunctionJan 12, 2021Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF L3 CONE FRACTURE IN NEED OF ANTERIOR L3 CONE RESECTION, SPINAL CANAL DECOMPRESSION, BONE GRAFT PEDICLE SCREW FIXATION AND FUSION USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW SLIPPED AND COULDN'T BE FIXED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WAS NO DELAY IN PROCEDURE TIME REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153139 ↗
• MalfunctionJun 1, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR 4-5 LAMINECTOMY, VERTEBRAL CANAL DECOMPRESSION, LUMBAR 4 VERTEBRA OPEN R EDUCTION, PEDICLE SCREW FIXATION SURGERY DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP, SCREW PLUG WAS SLIPPING WHEN SCREWING, AND THE SCREW COULD NOT BE FIXED. NO FRAGMENT OF THE IMPLANT WERE REMAINING IN THE PATIENT AND NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10104070 ↗
• MalfunctionNov 5, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT ANTERIOR LUMBAR 4-5 TUBERCULOSIS LESION CLEARANCE AND LUMBAR 4-5 INTERNAL FIXATION DUE TO SPINAL TUBERCULOSIS. INTRA-OP, SET SCREW PLUG SLIPPED DURING THE SURGERY. THE SET SCREW WAS REMOVED DURING THE SURGERY ITSELF. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9277265 ↗
• MalfunctionApr 30, 2018Failure to Align; Failure to Align

  PROCEDURE: ANTERIOR LUMBAR 2 VERTEBRAL BODY (PARTIAL) RESECTION, SPINAL DECOMPRESSION, FUSION FIXATION OF TITANIUM RETE SUPPORTING BONE AUTOGRAFT IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHILE DOCTOR USED THE SET SCREW TO TIGHTEN THE FINAL LOCK, THE SET SCREW OCCURRED SLIDING WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7471727 ↗
• MalfunctionApr 30, 2018Failure to Align; Failure to Align

  PROCEDURE: ANTERIOR LUMBAR 2 VERTEBRAL BODY (PARTIAL) RESECTION, SPINAL DECOMPRESSION, FUSION FIXATION OF TITANIUM RETE SUPPORTING BONE AUTOGRAFT IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHILE DOCTOR USED THE SET SCREW TO TIGHTEN THE FINAL LOCK, THE SET SCREW OCCURRED SLIDING WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7471726 ↗
• MalfunctionApr 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THROUGH LATERAL FRONTAL LUMBAR 3-4, LUMBAR 4-5 DISCECTOMY, LUMBAR 3-5 NERVE DECOMPRESSION, INTERBODY BONE GRAFT FUSION, ANTERIOR INTERNAL FIXATION DUE TO DEGENERATIVE SPONDYLOLISTHESIS AT 4 AND SPINAL CANAL STENOSIS AT LUMBAR 3-5. DURING THE SURGERY, THE SET SCREW SLIPPED WHICH COULD NOT BE LOCKED. HENCE, THE SET SCREW WAS COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7463857 ↗
• MalfunctionApr 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THROUGH LATERAL FRONTAL LUMBAR 3-4, LUMBAR 4-5 DISCECTOMY, LUMBAR 3-5 NERVE DECOMPRESSION, INTERBODY BONE GRAFT FUSION, ANTERIOR INTERNAL FIXATION DUE TO DEGENERATIVE SPONDYLOLISTHESIS AT 4 AND SPINAL CANAL STENOSIS AT LUMBAR 3-5. DURING THE SURGERY, THE SET SCREW SLIPPED WHICH COULD NOT BE LOCKED. HENCE, THE SET SCREW WAS COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7463849 ↗