CD Horizon™ ModuLeX™ Spinal System 559200009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000435714), received between Nov 17, 2022 and Dec 16, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• MalfunctionDec 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE L2-S1 PSF WITH L4-S1 TLIF. IT WAS REPORTED THAT WHILE FINAL TIGHTENING OF THE SET CAPS ONE OF THE SET CAPS SPLAYED AND WAS UNABLE TO BE TORQUED DOWN, LEAVING THE RING OF THE SET CAP ATTACHED. THE BREAK OFF RING ON THE SET CAP IS STILL ATTACHED TO THE SET CAP AND IS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23818912 ↗
• MalfunctionMar 3, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT, SET SCREWS WERE STRIPPED DURING FINAL TIGHTENING. HAD TO REMOVE AND REPLACE WITH NEW SET SCREWS. IT WAS FOUND THAT THE TIP OF POWEREASE BREAKOFF DRIVER LOOKS WORN AND IT WAS CONTRIBUTING TO STRIPPING OF SET SCREWS. PROCEDURE/TECHNIQUE PERFORMED WAS POSTERIOR SPINAL FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502212 ↗
• InjuryMar 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA DISTRIBUTOR REGARDING A PATIENT UNDERWENT SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT, PATIENT HAD SOME MILD INCREASE IN PAIN NEARLY FOR 4 MONTHS AFTER THE SURGERY. SET CAPS DID NOT HOLD THE RODS AS NEEDED. THE ROD CAME OUT OF THE SET CAP AND SCREWHEAD AFTER THE SURGERY. X-RAY PERFORMED ON (B)(6) 2025 SHOWS RODS NO LONGER HELD BY ORIGINAL CONSTRUCT AT L3. THE LEVELS IMPLANTED WERE T3-L3. PROCEDURE/TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY. PATIENT UNDERWENT REVISION SURGERY, AND THE REPORTED PRODUCTS WERE EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 21502034 ↗
• InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION, PSF SEGMENTAL INSTRUMENTATION FOR SCOLIOSIS. IT WAS REPORTED THAT THE ROD SLIPPED FROM THE BOTTOM SCREW OF A SCOLIOSIS CONSTRUCT. THE SET CAP IS STILL TIGHTENED TO THE SCREW. TULIP OR SET SCREW HALFWAY OUT OF ROD. REVISION SURGERY PERFORMED ON (B)(6) 2024 AND PRODUCTS WERE REPLACED. LEVELS IMPLANTED WERE T2-L2 IN INITIAL SURGERY AND L2-L3 IN REVISION SURGERY. PATIENT HAD PAIN. NO NEUROLOGICAL COMPLICATIONS NOTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19496432 ↗
• InjuryNov 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED IN TLIF THERAPY. LEVELS IMPLANTED: L3-4 IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED WITH A REDUCTION OF A SPONDYLOLISTHESIS AT L3/4. AFTER THE SPONDYLOLISTHESIS WAS REDUCED, THE SURGEON COMPRESSED TO GAIN LORDOSIS AT THIS SEGMENT. IMAGES WERE TAKEN IN THE ROOM AFTER FINAL TIGHTENING AND IT SHOWED THAT THERE WAS A REDUCTION PERFORMED WITH THE ROD ABOVE AND BELOW THE SCREWS. FOLLOW-UP IMAGES WERE THEN TAKEN IN THE CLINIC ON (B)(6) 2022, WHICH SHOWED THAT THE LEFT - L3 SET SCREW CAME LOOSE AND WAS NO LONGER ATTACHED TO THE POLY HEAD OF THE LEFT - L3 SCREW. THIS FAILURE CAUSED THE LORDOSIS GAINED FROM THE COMPRESSION TO BE LOST AS WELL AS THE SPONDYLOLISTHESIS TO REOCCUR ONCE THE SET SCREW FAILED. AN EXPLANT SURGERY WAS PERFORMED TO CORRECT THIS ISSUE ON (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 15813358 ↗