CD HORIZON® Spinal System 7540220Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00885074468174), received between Dec 15, 2017 and Nov 25, 2025 — classified as 10 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (13 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, 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR DECOMPRESSION, FUSION, AND INTERNAL FIXATION SURGERY (GRADE III) DUE TO LUMBAR DISC HERNIATION. IT WAS REPORTED THAT WHILE IMPLANTING THE END CAP, THE DOCTOR ENCOUNTERED THREAD STRIPPING OF THE NUT, RESULTING IN MISALIGNMENT OF THE THREADS. 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 23642119 ↗
• MalfunctionMar 3, 2025Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR INTERVERTEBRAL FUSION THROUGH THE INTERVERTEBRAL FORAMEN APPROACH FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT A LEGACY SCREW EXPERIENCED A SLIPPERY THREAD MALFUNCTION. THE PROCEDURE INVOLVED THE USE OF A BONE SCREW AND A SET SCREW, BOTH OF WHICH WERE EXPLANTED DUE TO THE ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SET SCREW WAS WORN. SET SCREW OCCURRED SLIPPERY THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502549 ↗
• MalfunctionSep 28, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR 4/5 DISC HERNIATION. IT WAS REPORTED THAT THE SET SCREWS COMPLAINED OF WERE ALL SERIOUSLY SLIPPERY AND COULD NOT BE USED NORMALLY,THERE WAS A WRONG LOCK BETWEEN THE SCREW AND SET SCREW, WHICH AFFECTED THE FINAL LOCKING EFFECT, SO IT WAS TAKEN OUT 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 15500769 ↗
• MalfunctionSep 28, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR 4/5 DISC HERNIATION. IT WAS REPORTED THAT THE SET SCREWS COMPLAINED OF WERE ALL SERIOUSLY SLIPPERY AND COULD NOT BE USED NORMALLY,THERE WAS A WRONG LOCK BETWEEN THE SCREW AND SET SCREW, WHICH AFFECTED THE FINAL LOCKING EFFECT, SO IT WAS TAKEN OUT 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 15500602 ↗
• MalfunctionSep 28, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR 4/5 DISC HERNIATION. IT WAS REPORTED THAT THE SET SCREWS COMPLAINED OF WERE ALL SERIOUSLY SLIPPERY AND COULD NOT BE USED NORMALLY,THERE WAS A WRONG LOCK BETWEEN THE SCREW AND SET SCREW, WHICH AFFECTED THE FINAL LOCKING EFFECT, SO IT WAS TAKEN OUT 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 15500597 ↗
• MalfunctionSep 28, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR 4/5 DISC HERNIATION. IT WAS REPORTED THAT THE SET SCREWS COMPLAINED OF WERE ALL SERIOUSLY SLIPPERY AND COULD NOT BE USED NORMALLY,THERE WAS A WRONG LOCK BETWEEN THE SCREW AND SET SCREW, WHICH AFFECTED THE FINAL LOCKING EFFECT, SO IT WAS TAKEN OUT 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 15500553 ↗
• MalfunctionAug 22, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN POSTERIOR LUMBAR DECOMPRESSION FUSION INTERNAL FIXATION THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW THREAD SLIPPED. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263947 ↗
• MalfunctionAug 22, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN POSTERIOR LUMBAR DECOMPRESSION FUSION INTERNAL FIXATION THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW THREAD SLIPPED. THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263938 ↗
• MalfunctionMar 17, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR AND HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN A POSTERIOR LUMBAR INTERBODY GRAFT FUSION FOR A LUMBAR DISC HERNIATION. IT WAS REPORTED THAT WHEN THE SCREWS WERE IMPLANTED, THEY WERE SCREWED INTO THE WRONG THREAD CAUSING THE SCREWS TO SLIP. THE SCREWS HAD BEEN IN CONTACT WITH THE PATIENT DURING THE PATIENT'S SURGICAL IMPLANTATION PROCESS. WHEN IT WAS FOUND THAT THE SCREWS SLIPPED, THEY WERE REMOVED. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE DATES OF IMPLANT AND EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13799292 ↗
• MalfunctionNov 29, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIDING WIRE. POSTERIOR DISCECTOMY WAS PERFORMED, AND POSTERIOR LUMBAR WAS FIXED WITH A SCREW ROD. THE PRODUCT HAS BEEN IN CONTACT WITH THE PATIENT, BUT HAS BEEN REMOVED AFTER SLIPPING. 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 12880418 ↗
• MalfunctionNov 29, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIDING WIRE. POSTERIOR DISCECTOMY WAS PERFORMED, AND POSTERIOR LUMBAR WAS FIXED WITH A SCREW ROD. THE PRODUCT HAS BEEN IN CONTACT WITH THE PATIENT, BUT HAS BEEN REMOVED AFTER SLIPPING. 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 12880406 ↗
• MalfunctionNov 23, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A LUMBAR INTERNAL FIXATION FOR A LUMBAR DEGENERATION. IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW PLUGS SLIPPED. THE SCREW PLUGS WERE REMOVED COMPLETELY AFTER IMPLANTATION. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859057 ↗
• MalfunctionJan 12, 2021Device Slipped; Device Damaged by Another Device; Device Slipped; Device Damaged by Another Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN POSTERIOR THORACOLUMBAR SURGERY. IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE SCREW PLUG WAS TIGHTENED, THE TIP OF THE TOOL DRIVER WAS BROKEN IN THE SCREW PLUG, MAKING THE SCREW PLUG UNUSABLE. IN THE PROCESS OF LOCKING THE CROSSLINK, THE SCREW PLUG WAS TIGHTENED, AND THE SCREW PLUG WAS SLIPPED. AS A RESULT, CROSSLINK COULD NOT BE LOCKED AND IT COULD NOT BE INSTALLED. REPORTED SET SCREW WAS NOT IMPLANTED. NO FRAGMENTS LEFT IN THE PATIENT'S BODY. EVENT WAS ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153769 ↗
• MalfunctionSep 18, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR LUM BAR DISC HERNIATION, LUMBAR 4,5 SLIP. IT WAS REPORTED THAT THE SCREW PLUG SLIPPED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 10551854 ↗
• MalfunctionJun 26, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SCOLIOSIS; AND UNDERWENT POSTERIOR LUMBAR DECOMPRESSION AND FUSION SURGERY. INTRA-OP, WHILE INSERTION, THE SET SCREW SLIPPED. HENCE, THIS SET SCREW WAS REMOVED FROM THE PATIENT, AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10203295 ↗
• MalfunctionJan 16, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS : LUMBAR DEGENERATIVE PROCEDURE: LUMBAR INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, SET SCREW WAS SLIPPED DURING THE OPERATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253095 ↗
• MalfunctionJan 16, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: LUMBAR DEGENERATIVE PROCEDURE: LUMBAR INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, SET SCREW WAS SLIPPED DURING THE OPERATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253093 ↗
• MalfunctionOct 17, 2018Failure to Align; Failure to Align

  PROCEDURE: LUMBAR SPONDYLOLISTHESIS PRE-OPERATIVE DIAGNOSIS: LUMBAR SPONDYLOLISTHESIS IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS AND COMPLICATION WERE REPORTED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975985 ↗
• InjuryJul 19, 2018Defective Component; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7703483 ↗
• InjuryJul 19, 2018Defective Component; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7703482 ↗
• InjuryJul 19, 2018Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSUEDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7703477 ↗
• InjuryJul 19, 2018Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7703476 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7703455 ↗
• InjuryJul 19, 2018Defective Component; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7703433 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NEUROMUSCULAR SCOLIOSIS AND UNDERWENT CONSTRUCT FIXATION AT T2-PELVIS. REPORTEDLY POST-OP, THE SET SCREW FAILED AND PATIENT HAD PSEUDOARTHROSIS. ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE CONSTRUCT WAS EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7703431 ↗