CD HORIZON® Spinal System 75445540Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00885074134017), received between Dec 8, 2016 and Sep 26, 2024 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Corroded; Biocompatibility; Material Twisted/Bent; Corroded; Biocompatibility; Material Twisted/Bent

  INFORMATION RECEIVED FROM CONSUMER, MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED IMPLANTS. IT WAS REPORTED THAT, PATIENT WAS ALLERGIC TO NICKEL AND EXPERIENCING SYMPTOMS. REVISION SURGERY WAS PLANNED. NO FURTHER COMPLICATIONS REPORTED. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT THE LEVELS L1-L3. INITIAL SURGERY WAS PERFORMED IN THE (B)(6) 2007. NO FURTHER COMPLICATIONS REPORTED PATIENT APPEARED FOR EXISTING L2 FRACTURE, STATUS POST L1-L3 FUSION WITH INSTRUMENTATION, PRESENTED FOR REVISION SURGERY. THE REVISION SURGERY WAS PERFORMED FOR RE-EXPLORATION OF THE L2 FRACTURE, T12-L3 FUSION EXTENSION, REPAIR OF TONGUE LACERATION, REVISION OF THE INSTRUMENTATION DUE TO HARDWARE LOOSENING. THE PRODUCTS WERE EXPLANTED DURING REVISION SURGERY AND SENT TO LAB FOR FORENSIC ANALYSIS, IT WAS DISCOVERED THAT THERE WAS CORROSION AND BENDING OF RODS. IT WAS STATED THAT, IN 2022 PATIENT DEVELOPED METALLOSIS AND ADVERSE LOCAL TISSUE REACTIONS (ALTR) THROUGH HEAVY METAL URINE TESTS AND MRI IMAGING. PATIENT HAD SERIOUS SOFT TISSUE ISSUES THROUGHOUT HIS BODY AND LAST WEEK IT WAS TOLD THAT HE WILL NEED ALL THE TEETH REMOVED

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Autoimmune Disorder; Cerebrospinal Fluid Leakage; Foreign Body Reaction; Inflammation; Metal Related Pathology; Neuropathy; Rash; Swelling/ Edema; Swollen Lymph Nodes/Glands

  MAUDE report 20307594 ↗
• InjuryMay 6, 2024Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST L4 <(>&<)> L5 LUMBER SPINE FIXATION THROUGH POSTERIOR APPROACH, TRANSPEDICULAR IN A PATIENT DIAGNOSED WITH SPINAL CORD STENOSIS. IT WAS REPORTED THAT PEDICLE SCREW HEAD GOT DISENGAGED FROM THE SCREW SHAFT 2 DAYS AFTER THE SURGERY. PATIENT COMPLAINED OF BACK PAIN <(>&<)> ELEVATION WAS SEEN ON THE SKIN. REVISION SURGERY WAS DONE TO REPLACE THE FAULTY IMPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19247000 ↗
• InjuryMay 6, 2024Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST L4 <(>&<)> L5 LUMBER SPINE FIXATION THROUGH POSTERIOR APPROACH, TRANSPEDICULAR IN A PATIENT DIAGNOSED WITH SPINAL CORD STENOSIS. IT WAS REPORTED THAT PEDICLE SCREW HEAD GOT DISENGAGED FROM THE SCREW SHAFT 2 DAYS AFTER THE SURGERY. PATIENT COMPLAINED OF BACK PAIN <(>&<)> ELEVATION WAS SEEN ON THE SKIN. REVISION SURGERY WAS DONE TO REPLACE THE FAULTY IMPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19246990 ↗
• InjuryJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ARTHRODESIS SURGERY. IT WAS REPORTED THAT ONE OF THE SCREWS IMPLANTED ON (B)(6) 2021 WAS BROKEN AND ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE BROKEN 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 14751226 ↗
• InjuryDec 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR POSTERIOR FIXATION WITHOUT CAGE. IT WAS REPORTED THAT THE SCREW BROKE POST OPERATIVELY. PRODUCT REMAINS IN PATIENT. SURGERY WAS SCHEDULED TO REMOVE THE BROKEN SCREW AND REPLACE IT WITH A SIMILAR ONE. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WAS NO KNOWLEDGE OF THE EXACT DATE OF OCCURRENCE OF SCREW BREAKAGE. DOCTOR REPORTS THAT THE PATIENT HAD LOW BACK PAIN, WITH NO APPARENT CAUSATIVE FACTOR, 41 DAYS AFTER SURGERY, WHICH ON THE FOLLOWING DAY BECAME ASSOCIATED WITH LUMBAR SCIATIC PAIN AND THEN SIGNIFICANTLY INTENSIFIED. ONLY THEN DID THEY ORDER IMAGING TESTS AND DETECT THE BROKEN SCREW. ADDITIONAL SURGICAL OR MEDICAL INTERVENTION PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 13019009 ↗
• MalfunctionNov 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 FUSION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. IMPLANTED AND REPLACED WITH A NEW SCREW. THE DEVICE WAS REPLACED, AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THE PATIENT HAD BACK PAIN AS SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 10827444 ↗
• MalfunctionNov 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 FUSION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. IMPLANTED AND REPLACED WITH A NEW SCREW. THE DEVICE WAS REPLACED AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THE PATIENT HAD BACK PAIN AS SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 10827435 ↗
• MalfunctionNov 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 FUSION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. IMPLANTED AND REPLACED WITH A NEW SCREW. THE DEVICE WAS REPLACED AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THE PATIENT HAD BACK PAIN AS SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 10827416 ↗
• InjuryJan 22, 2020Break; Break

  POST-OP, THE IMPLANTED SCREW BROKE AND PATIENT SUFFERED FROM SEVERE PAIN IN RIGHT LOWER LIMB AND THE LUMBAR REGION. FOR THE REMOVAL OF BROKEN SCREW THE PATIENT UNDERWENT REVISION SURGERY. THE EVENT PROCEEDED WITHOUT COMPLICATIONS. THE OPERATOR WAS HAPPY WITH THE RESULT.

  Patient problems: Pain

  MAUDE report 9615523 ↗
• InjuryJan 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY. POST-OP, THE IMPLANTED SCREW BROKE AND PATIENT SUFFERED FROM SEVERE PAIN IN RIGHT LOWER LIMB AND THE LUMBAR REGION. FOR THE REMOVAL OF BROKEN SCREW THE PATIENT UNDERWENT REVISION SURGERY. THE EVENT PROCEEDED WITHOUT COMPLICATIONS. THE OPERATOR WAS HAPPY WITH THE RESULT.

  Patient problems: Pain

  MAUDE report 9615508 ↗
• InjuryDec 24, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT L2-S. POST-OP, THE SCREWS IMPLANTED AT L2-L3 BROKE DUE TO WHICH THERE WAS PSEUDOARTHROSIS AT THIS LEVEL. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, IN WHICH THE BROKEN SCREWS WERE EXPLANTED AND REPLACED WITH NEW ONES. NO FRAGMENT OF THE BROKEN SCREWS REMAINED IN THE PATIENT'S BODY. PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 8194502 ↗
• InjuryDec 24, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT L2-S. POST-OP, THE SCREWS IMPLANTED AT L2-L3 BROKE DUE TO WHICH THERE WAS PSEUDOARTHROSIS AT THIS LEVEL. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, IN WHICH THE BROKEN SCREWS WERE EXPLANTED AND REPLACED WITH NEW ONES. NO FRAGMENT OF THE BROKEN SCREWS REMAINED IN THE PATIENT'S BODY. PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 8194501 ↗
• MalfunctionJun 21, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR INSTRUMENTATION FOR SCOLIOSIS. INTRA-OPERATIVE, SCREW HEAD WAS BROKEN WHILE TIGHTENING OF NUT. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO FRAGMENTS OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6656167 ↗
• InjuryDec 13, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A L4 DECOMPRESSION PROCEDURE AND UNDERWENT REMOVAL OF PEDICLE DUE TO SYNTRIPSIS. ON AN UNKNOWN DATE, POST-OP,SCREWS BROKE. PATIENT UNDERWENT REVISION SURGERY IN WHICH THE SCREWS WERE PARTIALLY EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 6172754 ↗
• InjuryDec 8, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A L4 DECOMPRESSION PROCEDURE AND UNDERWENT REMOVAL OF PEDICLE DUE TO SYNTRIPSIS. ON AN UNKNOWN DATE, POST-OP, SCREW BROKE. PATIENT UNDERWENT REVISION SURGERY IN WHICH THE SCREWS WERE PARTIALLY EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 6153781 ↗

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-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-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-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
• 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