CD HORIZON® Spinal System 54840006545Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994579614), received between Feb 12, 2017 and Apr 16, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K091974); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Align; Mechanical Jam; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION AT LEVELS L4-L5 FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT DURING SEATING WITH THE DRIVER, THE SCREW WOULD NOT SIT STRAIGHT AFTER 7 ATTEMPTS THROUGHOUT THE PROCEDURE. THE MAS HEAD COMPONENT DID NOT MOVE FREELY AND SEEMED TO BE STUCK. 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 24893183 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY VIA HEALTHCARE PROVIDER (HCP) AND A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6). THE PATIENT EXPERIENCED PSEUDARTHROSIS (NONUNION) WITH AN ONSET DATED ON (B)(6) 2025. THIS ADVERSE EVENT IS CONSIDERED SERIOUS DUE TO THE NEED FOR HOSPITALIZATION AND MEDICAL/SURGICAL INTERVENTION; IT WAS NOT LIFE-THREATENING, DID NOT RESULT IN DISABILITY, AND DID NOT INVOLVE A CONGENITAL ANOMALY OR DEATH. THE SITE BECAME AWARE OF THE EVENT ON 05 DEC 2025, AND IT OCCURRED IN THE POST-SURGICAL PERIOD FOLLOWING THE INDEX SPINAL PROCEDURE. THE INDEX PROCEDURE WAS AN IMPLANTED SPINAL SURGERY PERFORMED ON (B)(6) 2024. CLINICALLY, THE PATIENT REPORTED PERSISTENT POSTOPERATIVE PAIN. THE INITIAL DIFFERENTIAL DIAGNOSIS INCLUDED INFECTION VERSUS PSEUDARTHROSIS. PREOPERATIVE DIAGNOSTIC TESTING WAS NEGATIVE FOR INFLAMMATION, DECREASING THE LIKELIHOOD OF AN INFECTIOUS PROCESS. PSEUDARTHROSIS WAS SUBSEQUENTLY CONFIRMED INTRAOPERATIVELY DURING AN ADDITIONAL SPINAL SURGERY PERFORMED ON (B)(6) 2025. THE PATIENT REQUIRED A NEW HOSPITALIZATION BEGINNING ON (B)(6) 2025, WITH DISCHARGE ON (B)(6) 2025. INTERVENTIONS INCLUDED THE ADDITIONAL SPINAL SURG

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23960279 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL HISTORY: STENOSIS OF LUMBOSACRAL SPINE RELATED DEVICE: DEVICE NAME: CD HORIZON SOLERA 4.75 - SCREW.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain; Spinal Cord Injury; Stenosis

  MAUDE report 23462205 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TYPE OF ADDITIONAL SURGERY: REVISION DEVICE WAS DESTROYED AT THE FACILITY.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain; Spinal Cord Injury; Stenosis

  MAUDE report 23462193 ↗
• InjuryFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING REMOVAL OF L4-L5 SCREWS AND HALF OF THE BROKEN RIGHT L5 SCREW WITH NEW POSTERIOR FUSION, L4, L5, S1 WITH SEGMENTAL HARDWARE AND POSTEROLATERAL ALLOGRAFT, AUTOGRAFT FUSION AND AN L1, L2, L3 LAMINECTOMY WITH L5 AND S1 LAMINECTOMY WITH BILATERAL FORAMINOTOMIES AT L1-L2, L2-L3, L3-L4, AND L5-S1. IT WAS REPORTED THAT THE RIGHT L5 SCREW WAS BROKEN INTO TWO PIECES. THE PIECE THAT WAS LOOSE WAS REMOVED AND END OF THE SCREW WAS RETAINED INTENTIONALLY. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21443974 ↗
• MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6). IT WAS REPORTED THAT DURING AN INDEX SURGERY, THERE WAS A PULL OUT OF T12 SCREWS WITH POST JUNCTIONAL KYPHOSIS, LEADING TO HARDWARE FAILURE. AN X-RAY DIAGNOSTIC TEST CONFIRMED THE PULL OUT OF T12 SCREWS WHICH WAS CLINICALLY SIGNIFICANT. THE OUTCOME OF THIS ADVERSE EVENT WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER COMPLICATIONS REPORTED. SITE RELATED ASSESSMENT: ADVERSE EVENT PROBABLY RELATED TO THE INDEX SURGERY. NOT RELATED TO A MEDTRONIC CST DEVICE. SPONSOR ASSESSMENT: ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE SPONSOR WAS DIFFERENT FROM INVESTIGATOR. THE ADVERSE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP WITH THE INDEX SURGERY. AND HAD CAUSAL RELATIONSHIP WITH THE STUDY DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT AS PER THE DEVICE IDENTIFICATION CRF FOR THE SUBJECT, HOWEVER NO INDICATION OF SPECIFIC DEVICE RELATIONSHIP HAS BEEN MADE BY THE SITE. BASED ON THE NATURE OF THE EVENT, SPONSOR CHOSE A CONSERVATIVE ASSESSMENT OF DEVICE RELATED UNTIL IT CAN BE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21430277 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ACUTE FRACTURE AT T12-L1. THE PATIENT CONTINUED TO EXPERIENCE PAIN AND WAS HOSPITALIZED FOR AN IN-PATIENT OR PROLONGED STAY. THE PATIENT UNDERWENT ADDITIONAL SPINAL SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Pain

  MAUDE report 21077471 ↗
• InjuryOct 3, 2024Break; Break

  INFORMATION WAS RECEIVED FROM CONSUMER (CON), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD POSTERIOR SPINAL FUSION FOR SPONDYLOLYSIS L5-S1 AND LEFT LEG RADICULOPATHY. LEVELS IMPLANTED WAS L5-S1. IT WAS REPORTED THAT THE SCREW WAS BROKEN AND THE DISTAL SCREW SHANK REMAINS IN THE PATIENTS LEFT S1 PEDICLE. THE PATIENT HAD PAIN AND REVISION SURGERY WAS PERFORMED AND EXPLANTED PARTIALLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN TO REMOVE THE REMAINING FRAGMENT AS IT IS COUNTERSUNK INTO THE SACRUM. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ON 2024-JUL-05 IS THE FIRST DOCUMENTATION OF WORSENING PAIN AND PATIENT SAID THAT THE PAIN STARTED ABOUT A MONTH PRIOR TO THAT CLINIC DATE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 20356877 ↗
• InjuryJun 14, 2024Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2024 MPXR 1182551 (REP, HCP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 POSTERIOR DECOMPRESSION AND SPINAL FUSION THERAPY FOR LUMBAR RADICULOPATHY. LEVELS IMPLANTED L4-S1 IT WAS REPORTED THAT THE DEVICE HAS BROKEN AND UPON EXPLANATION, THE L4 SET SCREW WAS FOUND TO BE LOOSE AND METAL SHAVINGS FROM THE ROD / SET SCREW INTERFACE WERE FOUND AROUND THE HEAD OF THE SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT NO FRAGMENTS/ SHAVINGS FROM SET SCREW WERE IRRIGATED AND SUCTIONED AWAY FROM PATIENT, HENCE NO FRAGMENTS REMAINED. PATIENT WAS BROUGHT TO OR FOR AND EXTENSION OF FUSION. UPON SURGICAL EXPOSURE, THE SET SCREW WAS FOUND TO BE LOOSE. DUE TO PSEUDOARTHROSIS L4/5, LOOSENING OF THE L4 SCREW IN THE BONE AND ADJACENT LEVEL DISEASE( POSSIBLE INFECTION), THE HARDWARE WAS REPLACED AND EXTENDED UP TO L3. PATIENT ALSO HAD POSSIBLE DISC DEGENERATION OF L3/4 DISC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 19536197 ↗
• InjuryAug 11, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, THE PATIENT UNDERWENT FUSION. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE AT S1. THE PATIENT ALSO EXPERIENCED ISOLATED BACK PAIN. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE ALL INSTRUMENTATION. ON THE FIRST DAY, POST REVISION SURGERY, PATIENT'S CONDITION WAS REPORTED AS STABLE AND RECOVERING.

  Patient problems: Pain

  MAUDE report 8881806 ↗
• InjuryAug 11, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, THE PATIENT UNDERWENT FUSION. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE AT S1. THE PATIENT ALSO EXPERIENCED ISOLATED BACK PAIN. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE ALL INSTRUMENTATION. ON THE FIRST DAY, POST REVISION SURGERY, PATIENT'S CONDITION WAS REPORTED AS STABLE AND RECOVERING.

  Patient problems: Pain

  MAUDE report 8881805 ↗
• InjuryJun 13, 2018Collapse; Collapse

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY. POST-OP, IT WAS REPORTED VIA A PATIENT CALL THAT THE DEVICE WAS COLLAPSING. ALLEGEDLY, THE PATIENT WAS SUFFERED WITH PAIN IN HER LEGS AND HIPS AND SHE COULDN'T FEEL HER FEET. REPORTEDLY, THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE IN WHICH THE DEVICE WAS EXPLANTED.

  Patient problems: Numbness; Pain

  MAUDE report 7595551 ↗
• InjuryMay 3, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION SURGERY AT L4-S1. POST-OP, SCREW BROKE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. THE SURGEON SAID THE PATIENT HAD TAKEN A FALL A YEAR AND A HALF AGO AND HE SAID THE BROKEN SCREWS WERE PROBABLY A RESULT OF THE FALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482720 ↗
• InjuryMay 3, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION SURGERY AT L4-S1. POST-OP, SCREW BROKE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. THE SURGEON SAID THE PATIENT HAD TAKEN A FALL A YEAR AND A HALF AGO AND HE SAID THE BROKEN SCREWS WERE PROBABLY A RESULT OF THE FALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482717 ↗
• InjuryFeb 12, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L4/S1. ON AN UNKNOWN DATE, POST-OP, THE PATIENT SAT DOWN AFTER SURGERY AT HOME AND FELT THE S1 SCREWS HAD BROKEN. AFTER THE SCREWS BROKE, HE COMPLAINED OF PAIN AGAIN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH NEW ONES. THE DISTAL ENDS OF THE SCREWS WERE LEFT IN THE SACRUM. THE PATIENT DID NOT ACHIEVE SOLID FUSION.

  Patient problems: No Code Available; Pain

  MAUDE report 6325032 ↗
• InjuryFeb 12, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L4/S1. ON AN UNKNOWN DATE, POST-OP, THE PATIENT SAT DOWN AFTER SURGERY AT HOME AND FELT THE S1 SCREWS HAD BROKEN. AFTER THE SCREWS BROKE, HE COMPLAINED OF PAIN AGAIN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH NEW ONES. THE DISTAL ENDS OF THE SCREWS WERE LEFT IN THE SACRUM. THE PATIENT DID NOT ACHIEVE SOLID FUSION.

  Patient problems: No Code Available; Pain

  MAUDE report 6325031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio