CD HORIZON® Spinal System 8116439Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00721902819667), received between Mar 7, 2018 and Dec 3, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE, THE T20 TORX DRIVER WAS STRIPPED. THE TIP OF THE DRIVER WAS FRACTURED AND CROSSLINK FRACTURED WHERE IT ATTACHES TO ROD. THE FRACTURED IMPLANTS OCCURRED PRIOR TO THE REVISION SURGERY ON 11/13. IT WAS SUSPECTED BY THE PHYSICIAN THAT THE IMPLANTS (SCREW AND CROSSLINK) FRACTURED DUE TO STRESS ON HARDWARE FROM NON-FUSION OF THE PATIENT. THE CROSSLINK AND SCREW WERE EXPLANTED FROM THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23701738 ↗
• MalfunctionSep 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED IN A SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE SURGEON HAD USED A NUT AT THE END OF THE ASSEMBLY TO PROTECT THE SCREW HEAD. WHEN TIGHTENING, THE SCREW THREAD BROKE AND METAL FILINGS APPEARED. THIS WAS AN ISOLATED INCIDENT. TO COMPENSATE FOR THE INCIDENT, A SECOND DEVICE OF THE SAME REFERENCE AND BATCH WAS USED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444109 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN LUMBAR FUSION T10-S2 DUE TO DEGENERATIVE DISC DISEASE. INTRA-OPERATIVELY, THE SET SCREW BROKE OFF AT THE THREAD LEVEL NOT AT THE SMOOTH BREAK OFF PORTION OF SET SCREW. METAL CUTTING BURR WAS USED TO CUT THE SET SCREW AND REMOVED CROSSLINK WITH VICEGRIPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT. NO FRAGMENT OF THE PRODUCT IS REMAINING IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8820261 ↗
• MalfunctionMar 31, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, INTRA-OP, WHEN THE SCREW WAS SCREWED, THE SCREW PLUG BROKE AT THE NON-BREAKING POINT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468024 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH THORACIC SPINAL CANAL STENOSIS AND UNDERWENT LAMINA OF THORACIC VERTEBRA CUTTING DECOMPRESSION ,CANALIS SPINALIS EXPANDED MOLDING, VERTEBRAL PEDICLE INTERNAL FIXATION OPERATION. INTRA-OP, CROSS LINK PLUG SCREW ABNORMALLY FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319728 ↗