CD Horizon ModuLeX Spinal SystemRecalls & reported problems across all models

We found 34 models of CD Horizon ModuLeX Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2022 and Sep 23, 2026 — classified as 34 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CD Horizon ModuLeX Spinal System problems

CD Horizon ModuLeX Spinal System models

34 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CD Horizon™ ModuLeX™ Spinal System 559200029

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  8 reports
• CD Horizon™ ModuLeX™ Spinal System 559200008

  Appliance, fixation, spinal intervertebral body
  6 reports
• CD Horizon™ ModuLeX™ Spinal System 559200009

  Thoracolumbosacral pedicle screw system
  5 reports
• CD Horizon™ ModuLeX™ Spinal System 559200028

  Appliance, fixation, spinal intervertebral body
  5 reports
• CD Horizon™ ModuLeX™ Spinal System 55904506545

  Thoracolumbosacral pedicle screw system
  4 reports
• CD Horizon™ ModuLeX™ Spinal System 559200007

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  4 reports
• CD Horizon™ ModuLeX™ Spinal System 55900105540

  Appliance, fixation, spinal intervertebral body
  3 reports
• CD Horizon™ ModuLeX™ Spinal System NAV5597413

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  3 reports
• CD Horizon™ ModuLeX™ Spinal System 559200010

  Appliance, fixation, spinal intervertebral body
  3 reports
• CD Horizon™ ModuLeX™ Spinal System 55904507540

  Thoracolumbosacral pedicle screw system
  2 reports
• CD Horizon™ ModuLeX™ Spinal System 5597416

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  2 reports
• CD Horizon™ ModuLeX™ Spinal System 559200027

  Appliance, fixation, spinal intervertebral body
  2 reports
• CD Horizon™ ModuLeX™ Spinal System 559200034

  Appliance, fixation, spinal intervertebral body
  2 reports
• CD Horizon™ ModuLeX™ Spinal System 559200098

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  2 reports
• CD Horizon™ ModuLeX™ Spinal System G55900206540

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System G55900207540

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 55900105545

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 55900107545

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 55900206545

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 55900206550

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System G559300156

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 5597419

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 report
• CD Horizon™ ModuLeX™ Spinal System NAV5597651

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200066

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200030

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200014

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200038

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200029

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200064

  Thoracolumbosacral pedicle screw system
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200102

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200058

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200065

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200028

  Appliance, fixation, spinal intervertebral body
  1 report
• CD Horizon™ ModuLeX™ Spinal System 559200034

  Thoracolumbosacral pedicle screw system
  1 report

Recent CD Horizon ModuLeX Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having posterior spinal fusion for adult degenerative disc disease at L5-S1 levels. It was reported that during a procedure, the set screw collar broke off prior to being fully seated. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865377 ↗
• MalfunctionJul 9, 2026Material Fragmentation; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, WHILE FINAL TIGHTENING SET SCREW, SURGEON REPORTED FINDING SMALL METAL SHARD AFTER BREAKING SET SCREW OFF. THE PROCEDURE WAS A POSTERIOR LUMBAR FUSION. THE CASE WAS AN L3-5. THE EVENT HAPPENED WHILE FINAL TIGHTENING THE RIGHT L4 SCREW. 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 25759014 ↗
• MalfunctionJul 9, 2026Material Fragmentation; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25758946 ↗
• MalfunctionJun 21, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR POSTERIOR FUSIONS AND OBLIQUE LATERAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE FIVE RATCHET HANDLE DID NOT RATCHET, CAN BE ATTRIBUTED TO NORMAL PRODUCT WEAR AND TEAR, END OF SLEEVE OF THE RATCHET LOCK DRIVER BROKE OFF REMOVING THE INSTRUMENT FROM A SCREW AND END PIECE OF INSERTER SNAPPED OUTSIDE OF PROCEDURE, PART BECAME WORN DOWN AFTER MANY USES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571864 ↗
• MalfunctionJun 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL PATIENT ID (B)(6), STUDY ID MDT22045CSTAIL / MDT22045CSTAIL, SUB EVENT 03. IT WAS REPORTED THAT, PATIENT WITH POST JUNCTIONAL KYPHOSIS WITH SEVERE COMPRESSION OF L2 AND CUT OUT OF SCREWS. SCHEDULED FOR REVISION T11-L3 FUSION. DESCRIPTION: POST-JUNCTIONAL KYPHOSIS. SITE RELATED ASSESSMENT: ADVERSE EVENT WAS PROBABLY RELATED TO STUDY DEVICE AND PROCEDURE. TOTAL ESTIMATED BLOOD LOSS WAS 150ML. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2026-FEB-04 LSH 1474990585 (REP, SDY): ADDITIONAL INFORMATION RECEIVED STATING ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 AND THE SCREWS WERE EXPLANTED. ADDITIONAL INFORMATION RECEIVED STATING PATIENT WAS HOSPITALIZED (B)(6) 2026. ADDITIONAL MEDICATION WAS ADMINISTERED AND SPINAL SURGERY WAS PERFORMED ON (B)(6) 2026. MEDICATIONS ARE AS FOLLOWS - FENTANYL 50UG DUE TO ADDITIONAL LUMBAR SURGERY (ANESTHESIA). STARTED ON (B)(6) 2026, ENDED ON (B)(6) 2026. HYDROMORPHONE 0.5MG DUE TO PAIN POST-LUMBAR SPINE SURGERY. STARTED ON (B)(6) 2026, ENDED ON (B)(6) 2026. HYDROMORPHONE 0.25MG DUE TO

  Patient problems: Stenosis

  MAUDE report 25455004 ↗
• MalfunctionMay 26, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ONE OF THE FOUR TULIPS AFTER APPLIED TO THE SCREW WOULD NOT THREAD ONTO THE MT25 MODULEX NAV DRIVER. AFTER THE CASE IT WAS ABLE TO GET IT TO LOAD BUT IT WAS NOT EASY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THE MT25 MODULEX NAV DRIVER DID NOT HAVE ANY MALFUNCTION/ALLEGATION. THE DRIVER HAD WORKED PERFECTLY FOR 5 OF THE OTHER 6 SCREWS THAT WERE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273825 ↗
• MalfunctionMay 22, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED IN SPINAL THERA PY. IT WAS REPORTED THAT THE SCREWS STRIPPED WHEN TRYING TO START IMPLANTING INTO THE PEDICLE SCREW. 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 25254833 ↗
• MalfunctionMay 22, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED IN SPINAL THERA PY. IT WAS REPORTED THAT THE SCREWS STRIPPED WHEN TRYING TO START IMPLANTING INTO THE PEDICLE SCREW. 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 25254565 ↗
• 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 ↗
• MalfunctionMay 12, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PREVIOUS ADULT DEFORMITY FUSION, T3-SACRUM. IT WAS REPORTED THAT UPON REDUCING THE SET SCREW INTO THE SCREW HEAD SURGEON SAW METAL SHAVINGS FROM THE RDRMAS SCREW AND SET SCREW FROM SEVERAL OF THEM. THERE WERE NO ISSUES OBSERVED FOR THE FINAL TIGHTENING OF THE SYSTEM. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THIS WAS A REVISION OF AN ADULT DEFORMITY SURGERY FROM C2-SACRUM WHERE MODULEX WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146349 ↗
• 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 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND STUDY ID (B)(6) HAVING SPINAL THERAPY FOR STENOSIS. IT WAS REPORTED THAT THERE IS BILATERAL PEDICLE SCREW LUCENCY. 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 25013885 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND STUDY ID (B)(6) HAVING SPINAL THERAPY FOR STENOSIS. IT WAS REPORTED THAT THERE IS BILATERAL PEDICLE SCREW LUCENCY. 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 25013646 ↗
• InjuryMar 12, 2026Mechanical Jam; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A REOPERATION FOR LOOSENING OF TWO SCREWS IMPLANTED AT L2/3 IN A POSTEROLATERAL LUMBAR FUSION PROCEDURE, THE REMOVED DEVICE WAS FOUND TO HAVE AN ADHERED SCREW HEAD AND SCREW THREAD RESULTING IN RESTRICTED MOTION, WITH MINIMAL MOVEMENT ACHIEVED ONLY WHEN FORCE WAS APPLIED, NO MALFUNCTION OF THE SET SCREW, NO PATIENT SYMPTOMS, AND NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577306 ↗

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