CD HORIZON® Spinal System 5540230Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169058750), received between May 16, 2018 and Oct 15, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR SPINE DECOMPRESSION AND FUSION WITH INTERNAL FIXATION SPINAL THERAPY FOR LUMBAR DISC DEGENERATION. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS A PROBLEM ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF THOSE MATERIALS USED IN THE DEVICE CONSTRUCTION AND NO SUSPECTED MANUFACTURING ISSUE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289686 ↗
• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR SPINE DE COMPRESSION AND FUSION WITH INTERNAL FIXATION SPINAL THERAPY FOR LUMBAR DISC DEGENERATION. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS A PROBLEM ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF THOSE MATERIALS USED IN THE DEVICE CONSTRUCTION AND NO SUSPECTED MANUFACTURING ISSUE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289319 ↗
• InjuryOct 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION L1-S2 FOR DDD. PATIENT MEDICAL HISTORY: HYPERTENSION, HEP A, PRE-DIABETES, OBESITY, HIGH CHOLESTEROL, BPH, GERD, SLEEP APNEA IT WAS REPORTED THAT THE SETSCREWS WERE FINAL TIGHTENED ONTO THE ROD. SET SCREWS POPPED OFF SO IT NEEDED TO BE REVISED. AN ADDITIONAL SURGERY IS REQUIRED FOR EXTENSION TO T11 AND REVISION OF RODS. IT IS UNKNOWN WHEN EXACTLY THE SETSCREWS POPPED OFF. IT WAS DISCOVERED IN POST OPERATIVE X-RAY DURING A CLINIC VISIT. INITIAL SURGERY DATE IS UNKNOWN AT THIS TIME. 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 15563021 ↗
• MalfunctionMar 7, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOLISTHESIS FIRST DEGREE INVOLVED IN THE LUMBAR SPONDYLOLISTHESIS SURGERY. LEVELS TREATED- L5 SEGMENT. IT WAS REPORTED THAT INTRA-OPERATIVELY, SOLERA LONG TAIL CAP SLIPPED. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13678254 ↗
• MalfunctionSep 9, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A LUMBAR INTERBODY FUSION FIXATION FOR A LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE HCP HAD A SLIPPAGE OF SCREW DURING THE SURGERY, SO HE APPLIED FOR A REPLACEMENT. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT AND EXPLANT OF SCREW WAS (B)(6) 2021. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12444940 ↗
• MalfunctionMay 20, 2021Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR DISC HERNIATION INVOLVED IN POSTERIOR LUMBAR SCREW FIXATION PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, THE SCREWDRIVER BROKE IN THE SCREW PLUG WHEN TIGHTENING. PRODUCT WAS NOT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-APR-27, RECEIVED ADDITIONAL INFORMATION THAT SCREWDRIVER BROKE IN THE SCREW PLUG AND NO FRAGMENT LEFT IN THE PATIENT'S BODY. DAMAGED SCREW WAS NOT IMPLANTED, AND IT WAS REPLACED. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854514 ↗
• MalfunctionFeb 23, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING POSTERIOR SLIP RESET PROCEDURE IN A PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SPACER BROKE, THE SC REWDRIVER'S HOLDING PATTERN WAS DAMAGED AND IT WAS IMPOSSIBLE TO SCREW AND THE SET SCREWS SLIPPED. CAGE WAS PULLED OUT WITH TOOLS ON THE SPOT, NO SECONDARY SURGERY. PRODUCTS WILL BE RETURNED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363838 ↗
• MalfunctionFeb 3, 2021Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH LUMBAR DISC HERNIATION INVOLVED IN POSTERIOR THORACOLUMBAR SURGERY/ INTERNAL FIXATION WITH SCREW ROD PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, WHEN TO BROKE THE SET SCREW TAIL, THE TOOL WAS BROKEN IN THE SET SCREW. AFTER REPLACING THE SET SCREW WITH A NEW ONE, IT WAS USED NORMALLY. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS NEVER IMPLANTED, REPLACED WITH MEDTRONIC PRODUCT. EVENT WAS ASSOCIATED WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE WAS NO ADDITIONAL SURGERY/TREATMENT PERFORMED AS A RESULT OF THE EVENT. PATIENT IS ALIVE AND NO INJURY. 2021-JAN-19, RECEIVED ADDITIONAL INFORMATION THAT EVENT OCCURRED DURING IMPLANTATION OF SCREW IN THE PATIENT. TOOL/DRIVER WAS REPLACED WITH ANOTHER ONE DURING THE PROCEDURE. 2021-JAN-28, RECEIVED ADDITIONAL INFORMATION THAT DRIVER WAS DISCARDED AFTER SURGERY. SET SCREW DID NOT BREAK. SETSCREW WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272322 ↗
• MalfunctionNov 11, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW FOR OPEN SURGERY. IT WAS REPORTED THAT SOLERA SCREW PLUG SLIPPED. IT SLIPPED INTRAOPERATIVELY, AND WAS IMMEDIATELY REMOVED AND STOPPED USING. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PRE-OP DIAGNOSIS WAS SPINAL DISEASE. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2020. THE DEVICE WAS EXPLANTED. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10821005 ↗
• MalfunctionNov 2, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR DEGENERATION INVOLVED IN SPINAL THERAPY. IT WAS REPORTED DURING PROCEDURE, SCREW PLUG SLIPPED. PRODUCT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THE EVENT. PATIENT WAS DISCHARGED FROM THE HOSPITAL. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10769774 ↗
• MalfunctionDec 11, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SPINAL INTERNAL FIXATION SYSTEM TYPE OF PROCEDURE: CHASING SCREW FIXATION IT WAS REPORTED THAT INTRA-OP, WHEN THE SURGEON NORMALLY USED THE TOOL TO LOCK, THE SCREW PLUG SLIPPAGE OCCURRED AND THE LOCK CANNOT BE FINALLY COMPLETED. THE SET SCREW WAS REPLACED WITH THE NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149906 ↗
• MalfunctionJul 26, 2018Failure to Align; Unintended Movement; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO LATERAL BENDING. INTRA-OP, SET SCREW SLIPPED DURING THE IMPLANTATION IN THE OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724590 ↗
• MalfunctionMay 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS AT T4-L3. INTRA-OP, SET SCREW STRIPPED. INITIALLY, SURGEON REDUCED THE ROD, STARTED SCREWS, AND DID PROVISIONAL TIGHTENING & COMPRESSION/DISTRACTION OF IMPLANTS. SURGEON THEN REMOVED SMART LINKS AND SET SCREW WAS THREADED CORRECTLY WITH NO CROSS THREADING (VISUAL INSPECTION) OCCURRED TILL THEN. SURGEON WENT TO BREAK OFF SET SCREW WITH INSTRUMENT AND THE SET SCREW ON THE LEFT SIDE ALL WOULD HAVE AN AUDIBLE CLICK BEFORE THEY BROKE OFF. UPON INSPECTION, THE MEDIAL SIDE OF THE SET SCREW SKIPPED UP A THREAD AND WAS NO LONGER SITTING FLUSH. THESE WERE NOT CROSS THREADED BEFORE FINAL BREAK OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517653 ↗
• MalfunctionMay 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS AT T4-L3. INTRA-OP, SET SCREW STRIPPED. INITIALLY, SURGEON REDUCED THE ROD, STARTED SCREWS, AND DID PROVISIONAL TIGHTENING & COMPRESSION/DISTRACTION OF IMPLANTS. SURGEON THEN REMOVED SMART LINKS AND SET SCREW WAS THREADED CORRECTLY WITH NO CROSS THREADING (VISUAL INSPECTION) OCCURRED TILL THEN. SURGEON WENT TO BREAK OFF SET SCREW WITH INSTRUMENT AND THE SET SCREW ON THE LEFT SIDE ALL WOULD HAVE AN AUDIBLE CLICK BEFORE THEY BROKE OFF. UPON INSPECTION, THE MEDIAL SIDE OF THE SET SCREW SKIPPED UP A THREAD AND WAS NO LONGER SITTING FLUSH. THESE WERE NOT CROSS THREADED BEFORE FINAL BREAK OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517650 ↗
• MalfunctionMay 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS AT T4-L3. INTRA-OP, SET SCREW STRIPPED. INITIALLY, SURGEON REDUCED THE ROD, STARTED SCREWS, AND DID PROVISIONAL TIGHTENING & COMPRESSION/DISTRACTION OF IMPLANTS. SURGEON THEN REMOVED SMART LINKS AND SET SCREW WAS THREADED CORRECTLY WITH NO CROSS THREADING (VISUAL INSPECTION) OCCURRED TILL THEN. SURGEON WENT TO BREAK OFF SET SCREW WITH INSTRUMENT AND THE SET SCREW ON THE LEFT SIDE ALL WOULD HAVE AN AUDIBLE CLICK BEFORE THEY BROKE OFF. UPON INSPECTION, THE MEDIAL SIDE OF THE SET SCREW SKIPPED UP A THREAD AND WAS NO LONGER SITTING FLUSH. THESE WERE NOT CROSS THREADED BEFORE FINAL BREAK OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517649 ↗
• MalfunctionMay 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS AT T4-L3. INTRA-OP, SET SCREW STRIPPED. INITIALLY, SURGEON REDUCED THE ROD, STARTED SCREWS, AND DID PROVISIONAL TIGHTENING & COMPRESSION/DISTRACTION OF IMPLANTS. SURGEON THEN REMOVED SMART LINKS AND SET SCREW WAS THREADED CORRECTLY WITH NO CROSS THREADING (VISUAL INSPECTION) OCCURRED TILL THEN. SURGEON WENT TO BREAK OFF SET SCREW WITH INSTRUMENT AND THE SET SCREW ON THE LEFT SIDE ALL WOULD HAVE AN AUDIBLE CLICK BEFORE THEY BROKE OFF. UPON INSPECTION, THE MEDIAL SIDE OF THE SET SCREW SKIPPED UP A THREAD AND WAS NO LONGER SITTING FLUSH. THESE WERE NOT CROSS THREADED BEFORE FINAL BREAK OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517648 ↗
• MalfunctionMay 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS AT T4-L3. INTRA-OP, SET SCREW STRIPPED. INITIALLY, SURGEON REDUCED THE ROD, STARTED SCREWS, AND DID PROVISIONAL TIGHTENING & COMPRESSION/DISTRACTION OF IMPLANTS. SURGEON THEN REMOVED SMART LINKS AND SET SCREW WAS THREADED CORRECTLY WITH NO CROSS THREADING (VISUAL INSPECTION) OCCURRED TILL THEN. SURGEON WENT TO BREAK OFF SET SCREW WITH INSTRUMENT AND THE SET SCREW ON THE LEFT SIDE ALL WOULD HAVE AN AUDIBLE CLICK BEFORE THEY BROKE OFF. UPON INSPECTION, THE MEDIAL SIDE OF THE SET SCREW SKIPPED UP A THREAD AND WAS NO LONGER SITTING FLUSH. THESE WERE NOT CROSS THREADED BEFORE FINAL BREAK OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517633 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.