CD HORIZON® Spinal System 75446540Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885074134116), received between Mar 3, 2017 and Jan 27, 2026 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

4 other recalls cover devices cleared under the same FDA submission (K042025); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREW H AVING L4-S1 FIXATION THERAPY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOWER BACK PAIN AND AN AWKWARD NOISE IN THE LOWER BACK POST-OPERATIVELY. X-RAY IMAGING REVEALED THAT THE SCREW WAS BROKEN AT THE S1 LEVEL. THERE WAS FRACTURE AT THE BASE OF RIGHT S1 PEDICLE SCREW ADJOINING THE POSTERIOR ROD. A MINIMAL ANTEROLISTHESIS OF L5 OVER S1 WITH BILATERAL L5 PARS INTERARTICULARIS DEFECTS WERE OBSERVED FOR THE PATIENT. THE EXPLANT REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Back pain

  MAUDE report 24186205 ↗
• MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE POSTERIOR LUMBAR D ECOMPRESSION AND INTERNAL FIXATION FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT DURING THE SURGERY, THE HEAD OF THE SCREW SEPARATED AND FELL OUT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574252 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR OPEN SURGERY FOR DEGENERATIVE DISEASES. IT WAS REPORTED THAT THE SCREWS WERE BROKEN DURING THE PROCEDURE. 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 21291542 ↗
• MalfunctionJan 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR LUMBAR INTERVERTEBRAL DISC HERNIATION, POSTERIOR DECOMPRESSION AND SCREW ROD FIXATION. PROCEDURE OR TECHNIQUE USED WAS PLIF (POSTERIOR DECOMPRESSION AND SCREW ROD FIXATION) IT WAS REPORTED THAT THE IMPLANT WAS BROKEN. SCREW DID NOT CAME IN CONTACT WITH THE PATIENT BODY. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076135 ↗
• MalfunctionNov 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT, THE SCREW WAS BROKEN. PROCEDURE OR TECHNIQUE PERFORMED WAS THORACO-LUMBAR OPEN PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794414 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR OPEN DECOMPRESSION AND BONE GRAFT FUSION WITH INTERNAL FIXATION. IT WAS REPORTED THAT WHEN ADJUSTING THE SCREW, THE IMPLANT HEAD AND SCREW SHAFT SEPARATED. 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 19507624 ↗
• MalfunctionMar 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 3-S1 LUMBER FIXATION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE SCREW BODY SEPARATED FROM HEAD. 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 18947659 ↗
• InjuryMar 16, 2023Break; Break

  ON (B)(6) 2018 CT SCAN OF THE LUMBAR SPINE CLINICAL NOTES: ANTERIOR SUBLUXATION OF L5 ON 81 ON X-RAY, SIGNIFICANT SCIATIC PAIN. TECHNIQUE: AXIAL SLICES WERE OBTAINED FROM T12 TO THE SACRUM IN CONJUNCTION WITH CORONAL AND SAGITTAL RECONSTRUCTIONS ON SOFT TISSUE AND BONE WINDOWS. FINDINGS: THERE ARE BILATERAL PARS INTERARTICULAR DEFECTS OF THE LAMINA OF L5 AND ASSOCIATED FORWARD SPONDYLOLISTHESIS OF L5 ON 81 BY APPROXIMATELY 8MM. THE INTERVENING DISC SPACE APPEARS SLIGHTLY NARROWED POSTERIORLY AND THERE. IS MILD SPONDYLOSIS AT THIS LEVEL. THE L4/5 DISC SPACE APPEARS MODERATELY NARROWED POSTERIORLY WITH MINIMAL SPONDYLOSIS. THE OTHER LUMBAR DISC SPACES ARE WELL MAINTAINED. THERE FS STRAIGHTENING OF THE UPPER LUMBAR LORDOSIS. NO BONY DESTRUCTIVE LESION OR PARASPINAL MASSES ARE SEEN. THE UPPER ABDOMINAL ORGANS AND BOWEL LOOPS VISUALIZED ARE UNREMARKABLE. THERE IS A LARGE RIGHT 1ST LUMBAR RIB AND A SMALL ONE ON THE LEFT. S1. IS SLIGHTLY TRANSITIONAL AND THERE ARE PERSISTENT FACET JOINTS AT THE 81/2 LEVEL WHICH APPEAR NORMAL. FROM T12 TO L4, THE DISCS DO NOT PROTRUDE SIGNIFICANTLY POSTERIORLY AND THERE IS NO SIGNIFICANT CANAL, FORAMINAL OR LATERAL RECESS STENOSES AT THESE LEVELS. THE FACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551274 ↗
• InjuryJun 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW IMPLANTED IN A PATIENT. IT WAS REPORTED THAT POST-OPERATIVELY, PATIENT FELT PAIN AND THE WENT TO THE SURGEON WHO FOUND THE SCREW WAS BROKEN AND THE VERTEBRAE MOVED FROM THE RIGHT POSITION. REVISION SURGERY WAS PERFORMED TO REMOVE BROKEN SCREW AND REPLACING WITH A NEW SCREW. PAIN WAS TREATED AFTER REMOVING THE BROKEN SCREW AND REPLACING IT WITH NEW SCREW. SURGEON WAS ABLE TO REMOVE ONLY PART OF THE SCREW. THE OTHER PART OF THE SCREW IS STILL IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 14852533 ↗
• InjuryAug 19, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH PEDICLE SCREW. THE PRE OP DIAGNOSIS WAS HERNIATED NUCLEUS PULPOSUS (HNP) (L5 -S1) AND PROCEDURE INVOLVED WAS STABILITASION LUMBAR TO ILLIAC. IT WAS REPORTED THAT THE PATIENT HAD COMPLAINTS OF SPINAL PAIN AND AFTER AN X-RAY THERE WAS A BROKEN SCREW IN S1, THE FIRST OPERATION OF THE PEDICLE SCREW WAS PERFORMED ON (B)(6) 2019. A REVISION SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. THE PRODUCT WAS EXPLANTED WILL BE REPLACED. THERE WERE NO OTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 10424693 ↗
• MalfunctionApr 4, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: LUMBAR OLISTHE TYPE OF PROCEDURE OR TECHNIQUE USED: LUMBAR SPONDYLOLISTHESIS WITH PEDICLE SCREW FIXATION AND BONE GRAFT FUSION IT WAS REPORTED THAT INTRA-OP, SCREW BROKE. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484036 ↗
• MalfunctionMar 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PEDICLE SCREW INTERNAL FIXATION AND BONE GRAFT FUSION DUE TO LUMBAR SPONDYLOLISTHESIS. IN TRA-OP, THE SCREW BROKE. THE IMPLANT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467807 ↗
• InjuryMar 29, 2019Break; Break

  PROCEDURE USED: ARTHRODESIS LUMBAR LEVELS: L4-L5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS BROKE. PATIENT REPORTED BACK PAIN DUE TO THE EVENT. THE SCREWS WERE EXPLANTED IN THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 8463405 ↗
• InjuryMar 29, 2019Break; Break

  PROCEDURE USED: ARTHRODESIS LUMBAR LEVELS: L4-L5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS BROKE. PATIENT REPORTED BACK PAIN DUE TO THE EVENT. THE SCREWS WERE EXPLANTED IN THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 8463392 ↗
• InjuryAug 8, 2018Break

  PRE-OP DIAGNOSIS: SCREWS ON L5 WAS BROKEN PROCEDURE USED: OPEN LUMBAR DECOMPRESSION PROCESS IT WAS REPORTED THAT POST-OP, SCREWS WERE FOUND TO BE BROKEN MORE THAN YEAR AFTER THE OPERATION. SCREW HEADS WERE REMOVED BUT REST OF THE PART REMAINED INSIDE THE L5. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7761347 ↗
• InjuryAug 8, 2018Break

  PRE-OP DIAGNOSIS: SCREWS ON L5 WAS BROKEN PROCEDURE USED: OPEN LUMBAR DECOMPRESSION PROCESS IT WAS REPORTED THAT POST-OP, SCREWS WERE FOUND TO BE BROKEN MORE THAN YEAR AFTER THE OPERATION. SCREW HEADS WERE REMOVED BUT REST OF THE PART REMAINED INSIDE THE L5. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7761344 ↗
• InjuryFeb 28, 2018Break; Break

  LEVELS IMPLANTED: L3-L5 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CENTRAL STENOSIS AND INSTABILITY AND UNDERWENT STABILIZATION WITH SCREWS. POST-OP, THE SCREW BROKE . REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. PART OF THE SCREW REMAINED IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302684 ↗
• InjuryFeb 28, 2018Break; Break

  LEVELS IMPLANTED: L3-L5 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CENTRAL STENOSIS AND INSTABILITY AND UNDERWENT STABILIZATION WITH SCREWS. POST-OP, THE SCREW BROKE . REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. PART OF THE SCREW REMAINED IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302682 ↗
• InjuryJul 14, 2017Break; Break

  IT WAS REPORTED THAT POST OP, ON AN UNKNOWN DATE, ONE SCREW WAS FOUND TO BE BROKEN AFTER 4.5 MONTHS OF IMPLANTATION. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO EXPLANT THE SCREW.

  Patient problems: No Code Available

  MAUDE report 6713263 ↗
• InjuryJul 12, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE AFTER 6 MONTHS. THE PATIENT UNDERWENT A REVISION SURGERY FOR REMOVAL.

  Patient problems: No Code Available

  MAUDE report 6705059 ↗
• InjuryMar 3, 2017Break; Break

  PRE-OP DIAGNOSIS: PREVIOUS L4-S1 TLIF PROCEDURE: L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) LEVELS INVOLVED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT REPORTED A FALL TO THE SURGEON WITH PAIN. X-RAY CONDUCTED ON (B)(6) 2016 SHOWED TWO BROKEN SCREWS. HENCE, SCREW WAS EXPLANTED IN A REVISION L4-S1 FUSION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 6375599 ↗
• InjuryMar 3, 2017Break; Break

  PRE-OP DIAGNOSIS: PREVIOUS L4-S1 TLIF PROCEDURE: L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) LEVELS INVOLVED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT REPORTED A FALL TO THE SURGEON WITH PAIN. X-RAY CONDUCTED ON (B)(6) 2016 SHOWED TWO BROKEN SCREWS. HENCE, SCREW WAS EXPLANTED IN A REVISION L4-S1 FUSION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 6375598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

• Z-0464-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
• Z-0465-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
• Z-2878-2011 · Jun 28, 2011 · Terminated
  ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat
• Z-2875-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a