CD Horizon™ ModuLeX™ Spinal System 559200029 (UDI 20763000972770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20763000972770), received between May 14, 2025 and May 20, 2026 — classified as 3 injuries, 5 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 20, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T7-T11 POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT DURING THE PROCEDURE, METAL SLIVERS FORMED AT THE SET SCREW AND HEAD INTERFACE WHEN PLACING THE SET SCREWS. IT WAS REPORTED THAT THE SET SCREWS WERE NOT CROSS THREADED. THE DEVICE REMAINED IMPLANTED AND IN SERVICE. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226992 ↗
• MalfunctionMay 19, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T7-T11 POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT DURING THE PROCEDURE, METAL SLIVERS FORMED AT THE SET SCREW AND HEAD INTERFACE WHEN PLACING THE SET SCREWS. IT WAS REPORTED THAT THE SET SCREWS WERE NOT CROSS THREADED. THE DEVICE REMAINED IMPLANTED AND IN SERVICE. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213521 ↗
• InjuryMay 6, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD REVISION SURGERY (T2 TO L4 POSTERIOR SPINAL FUSION) DUE TO SCREW PULL OUT. IT WAS REPORTED THAT DURING THE PROCEDURE, ONE OF THE L4 SCREWS WAS FOUND TO HAVE PULLED OUT OF THE BONE. ADDITIONALLY, FOUR TULIP HEADS WERE FOUND TO BE LOOSE ON THE ROD DESPITE THE SET SCREWS BEING IN THEIR FINAL TIGHTENED POSITION. ONE OF THE FOUR SET SCREWS HAD BROKEN OFF AND COULD NOT BE LOOSENED. THE TORQUE LIMIT BREAKOFF PIECE WAS BROKEN OFF AS IT SHOULD BE WHEN FOLLOWING THE FINAL TIGHTENING SURGICAL TECHNIQUE. THE REMAINING THREE SCREWS HAD SHANKS THAT WERE TIGHT IN THE BONE; HOWEVER, THEIR TULIP HEADS COULD STILL BE MOBILIZED DESPITE FINAL TIGHTENED SET SCREWS. THE LOOSE TULIPS WERE DISCOVERED IN INTEROP DURING THE REVISION. THERE WERE IMAGES SHOWING ONE SCREW AND ONE CABLE PULLED OUT SIX DAYS AFTER INITIAL SURGERY. THE AFFECTED COMPONENTS WERE PARTIALLY EXPLANTED.THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096189 ↗
• InjuryJan 16, 2026Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L2-PELVIS. IT WAS REPORTED THAT IT WAS HARD TO KNOW WHICH SET SCREW FROM THIS PACK IS LOOSE. ONE OF THE SET SCREWS IS NO LONGER IN THE SCREW TULIP AFTER IT WAS BROKEN OFF DURING THE CASE. THE RIGHT L2 SET SCREW HAS BACKED OUT OF THE SCREW¿S TULIP. SURGEON NOTICED SET SCREW OUT OF POSITION ON POST OP FOLLOW X-RAY. SURGEON DID NOT INDICATE A SYMPTOMS RELATED TO THE LOOSE SET SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE SET SCREW IS STILL IN THE PATIENT AND THE REPLACEMENT PROCEDURE IS SCHEDULED FOR (B)(6) 2025. THE PROCEDURE INVOLVED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION INVOLVING THE L2 VERTEBRA FUSED TO THE PELVIS AND THAT THERE WAS NO DELAY IN THE PROCEDURE. NO SPECIFIC COMPLICATION THAT I WAS MADE AWARE OF WITH THIS PATIENT. LEVEL IMPLANTED: THE LOOSE SET SCREW IS AT RIGHT L2. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT HCP REMOVED THE SET SCREW, AND THEN REPLACED IT WITH A NEW ONE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092363 ↗
• MalfunctionDec 26, 2025Break; Break

  PRE-OP DIAGNOSIS FOR THE PATIENT WAS DEGENERATIVE DISC DISEASE AND LEVEL IMPLANTED FOR PATIENT WAS L5. THERE WAS NO PROLONGED HOSPITALIZATION OR RE-OPERATION PERFORMED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895321 ↗
• MalfunctionDec 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING THORACOLUMBAR F USION FOR PEDIATRIC SCOLIOSIS. IT WAS REPORTED THAT WHILE PLACING SET SCREWS, SHAVING CAME OFF OF THE TULIP HEADS. 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 23740645 ↗
• MalfunctionSep 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF THE SET SCREWS (BREAKAWAY), A SMALL METAL SHARD WAS LEFT BEHIND. THERE IS NO REVISION SURGERY SCHEDULED AS THE SHARD/SHAVING WAS REMOVED IMMEDIATELY FOLLOWING VISUALIZATION OF IT. AND THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992109 ↗
• InjuryMay 14, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED VIA FOLLOW UP MPXR THAT THE HOSPITALIZATION END DATE UPDATED TO (B)(6) 2025 AND SITE PROCEDURE RELATIONSHIP UPDATED TO POSSIBLE RELATED TO THE INDEX PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteopenia/ Osteoporosis

  MAUDE report 22016094 ↗