CD Horizon® Spinal System 7078396Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20643169210183), received between Sep 8, 2020 and Sep 29, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 18, 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.

• MalfunctionSep 29, 2026Material Deformation

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for L3-IL rear fixation + L5/S Posterior Lumbar Interbody Fusion and Hernia LCS was the preoperative diagnosis of this surgery and there was a less than 60 mins delay in the overall procedure time. It was reported that all rods were installed and the final was performed, but during the final of the Iliac, there was a strange noise and a bur appeared, so the final (thread cutting) could not be finished. Even after replacing the set screw, the same issue occurred, so a new screw was swapped in and the final was performed without any issues. 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 50927337 ↗
• MalfunctionSep 29, 2026Material Deformation

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for L3-IL rear fixation + L5/S Posterior Lumbar Interbody Fusion and Hernia LCS was the preoperative diagnosis of this surgery and there was a less than 60 mins delay in the overall procedure time. It was reported that all rods were installed and the final was performed, but during the final of the Iliac, there was a strange noise and a bur appeared, so the final (thread cutting) could not be finished. Even after replacing the set screw, the same issue occurred, so a new screw was swapped in and the final was performed without any issues. 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 50927334 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR KYPHOSCOLIOSIS CORRECTION. IT WAS REPORTED THAT DURING A SPINAL SURGERY, TH9/L1 AND L3/SAI WERE SECURED SEPARATELY, AND EACH WAS CONNECTED WITH THE CONNECTOR USING THE OUTER ROD. AFTER FINAL TIGHTENING ON THE LEFT SIDE, THE RIGHT SIDE CONNECTOR SCREW BECAME STRIPPED DURING INSERTION. SUBSEQUENT ATTEMPTS TO REMOVE THE STRIPPED SCREW RESULTED IN THE T25 OBTURATOR BEING DAMAGED AND BECOMING STUCK INSIDE THE ASSEMBLY. BOTH THE AFFECTED IMPLANT AND INSTRUMENT WERE EXPLANTED AND REPLACED. THERE WAS A DELAY IN THE PROCEDURE OF LESS THAN 60 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT WHEN TIGHTENING THE SET SCREW ON THE TOP-OPEN SIDE OF THE CONNECTOR FOR THE FINAL TIME, IT TURNED FREELY AND COULD NOT BE SCREWED IN. AS A RESULT, AN ATTEMPT WAS MADE TO REMOVE THE CONNECTOR, BUT WHEN TRYING TO REMOVE THE SET SCREW ON THE SIDE-OPEN SIDE, THE TIP OF THE OBTURATOR BROKE OFF AND BECAME STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931666 ↗
• MalfunctionMay 18, 2025Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH DOMINO CONNECTORS HAVING SPINAL THERAPY. IT WAS REPORTED THAT PATIENT WAS REOPERATED FOR DISLODGING OF THE REPORTED DEVICE THAT WAS USED ON (B)(6) 2024.  AS A RESULT, THE SET SCREW OF THE DEVICE WAS LOOSE, SO IT WAS REPLACED WITH A NEW ONE. A ROD WAS ADDED TO DISTRIBUTE THE STRESS, AND WAS FINISHED. PATIENT SYMPTOM WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041300 ↗
• MalfunctionSep 19, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF THE EXISTING SPONDYLODESIS WITH S2 ALA ILEUM SCREWS AND CONNECTORS FOR A DOUBLE-ROD TECHNIQUE IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO BREAK OFF THE LOCKING SCREW, IT DIDN'T WORK. THE SCREW COULDN'T BE BROKEN OFF. THE SURGEON TRIED WITH 2 LOCKING SCREWS AND NEITHER COULD BE BROKEN OFF. THERE WAS METAL ABRASION BETWEEN THE THREAD OF THE CONNECTOR AND THE LOCKING SCREW, SO THAT NO SCREW COULD HOLD THEN. THEREFORE, THE CONNECTOR HAD TO BE REPLACED AND THE OPERATION TOOK LONGER. THERE WAS 60 MINS OF PROCEDURAL DELAY.  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 20258533 ↗
• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY FOR MATALOSIS. IT WAS REPORTED THAT THE SET SCREW DISLODGED FROM BALLAST SCREW. IMPLANT WAS EXPLANTED. NO DEBRIS LEFT INSIDE THE PATIENT BODY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT S2AI PROCEDURE WAS USED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017238 ↗
• MalfunctionDec 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SETSCREW LOOSE OCCURRED AFTER THE INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244811 ↗
• MalfunctionSep 27, 2023Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT WHEN INSERTING THE SET SCREW, THE COATING OF THE SET SCREW LET LOOSE IN THE SCREW AND SET SCREW WOULD NOT FIXATE. THE THREADING OF THE SET SCREW SEEMED DAMAGED AND THE COATING LET GO OF THE SET SCREW ITSELF. THIS REVISION SURGERY WAS PERFORMED AS PATIENT EXPERIENCED PAIN AFTER FIRST SURGERY DUE TO THE LENGTH OF THE CONSTRUCT. GOAL OF SURGERY WAS TO SHORTEN THE CONSTRUCT AND INCREASE THE MOBILITY OF THE PATIENT. THERE WERE NO PRODUCT ALLEGATION/MALFUNCTION ASSOCIATED WITH ANY OF THE MDT PRODUCTS THAT WERE USED IN INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823522 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN ANTERIOR OLIF AND POSTERIOR T9/S2 FIXATION WERE PERFORMED BY ASD. IT WAS REPORTED THAT THE SET SCREW OF THE SAI SCREW DISLODGED, SO TWO SCREWS ON ONE SIDE WERE ADDED TO THE ILIUM, AND THE ROD WAS PLACED. THE RIGHT ROD WAS ALSO BROKEN ABOVE THE S1 SCREW, SO THE S1PS WAS REMOVED AND CONNECTED USING THE ROD. THE RIGHT S1 SCREW WAS ALSO REPLACED. THE TAIL SIDE ROD WAS REMOVED WHICH HAD BEEN BROKEN ON THE S1 SCREW. THE HEAD SIDE ROD WAS NOT REMOVED, REMAINS IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323168 ↗
• InjuryApr 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L5/S BONE FUSION FAILURE, S2AI SET SCREW DISLODGEMENT. DATE OF INITIAL SURGERY- FIRST TIME: (B)(6) 2021, SECOND TIME: (B)(6) 2022 INITIAL SURGERY OR THE PROCEDURE TAKEN: TH4-S2AI L4/5/S PLIF (ADULT SPINAL DEFORMITY) IT WAS REPORTED THAT THE PATIENT WAS INITIALLY FIXED WITH TH4-S2AI, THEN IT WAS ONCE REPLACED WITH S2AI BY REOPERATION AND CONNECTED WITH MRC WITH DOUBLE S2AI ON BOTH SIDES AND PARALLEL ROD EXTENSION TO THE CRANIAL SIDE.  RIGHT SET SCREW CAME OFF AND REPLACEMENT RE-OPERATION WAS PERFORMED. THE INNER ROD WAS EXTENDED TO L2 AND IT WAS IN CONTACT WITH THE MRC, SO IT WAS DEPLOYED BELOW L2. WHEN ALL THE IMPLANTS WERE EXPOSED, IT WAS FOUND THAT THE TWO S2AI SET SCREWS ON THE RIGHT SIDE HAD COME OFF AS SHOWN IN THE XRAY, BUT THE SET SCREW ON THE LEFT SIDE HAD ALSO COME OFF ON THE CRANIAL SIDE. IN ADDITION, THE S2AI SCREWS ON BOTH CAUDAL SIDES HAD RODS DETACHED FROM THE HEAD ON BOTH SIDES. ON THE LEFT SIDE, THE SET SCREW WAS NOT DETACHED, BUT THE ROD WAS DETACHED FROM THE HEAD, WHICH SURPRISED THE DOCTOR. FIRST, THE PROLOCK BETWEEN L4/5 WAS REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661545 ↗
• InjuryMar 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SET SCREW USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW OF SAI SCREW USING BALLAST CAME OFF. SET SCREWS ON BOTH SIDES OF BALLAST CAME OFF. THIS WAS AN INCIDENT OF POSTOPERATIVE SET SCREW DISLODGEMENT WHEN USING THE BALLAST OPEN SCREWS. THERE WERE 4 SET SCREWS IN ONE SET AND 2 OF THEM HAVE DISLODGED. THE INITIAL SURGERY WAS DONE ON (B)(6) 2021 USING SOLERA5.5/6.6 BALLAST MRC IN PSF, FIXED RANGE T9/S2 THERAPY FOR LUMBAR POSTERIOR SCOLIOSIS. A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2023 FOR RE-FIXING OF BALLAST DUE TO DISLODGED SET SCREWS; REINFORCEMENT WITH RODS. THE SET SCREWS HAVE BEEN REMOVED AT THE HOSPITAL AND ILIAC SCREWS HAVE BEEN ADDED ON BOTH SIDES. THESE ARE CONNECTED AND REINFORCED WITH MRC CONNECTORS. THE SCREWS ARE EXPECTED TO BE RETURNED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633269 ↗
• InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS-DEGENERATIVE LUMBAR SCOLIOSIS INVOLVED IN THE POSTERIOR SPINAL FUSION (PSF) AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. LEVELS IMPLANTED- T9-S2AI. IT WAS REPORTED THAT DURING USE, ROD WAS BROKEN AT T11/12, L4/5, L5/S ONLY ON THE LEFT SIDE. PRODUCTS WERE USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO BROKEN FRAGMENTS LEFT IN THE PATIENT'S BODY. ADDITIONAL SURGERY- REPLACEMENT AND REINFORCEMENT DUE TO ROD BREAKAGE WAS PERFORMED. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. IT SEEMED THAT THE PATIENT COULD NOT VISIT THE HOSPITAL FOR ABOUT 5 YEARS, AND IT WAS UNKNOWN WHEN THE ROD BROKE. THERE WERE 3 BREAKS ON THE LEFT SIDE. THE VIEW WAS THAT THE ROD OF L5/S PROBABLY BROKE AND SUSPECTED THAT THE ROD OF L4/5 BROKE DUE TO THE FRACTURE OF L4. ROD BROKE ONLY ON THE LEFT SIDE BUT THE NUT ON THE RIGHT SIDE LOOSENED. PATIENT MEDICAL HISTORY: HT, CARDIAC DISORDER INITIAL SURGERY DETAIL- T9-S2AI: PSF AND L2/3/4/5/S: TLIF. SO56. CAGE WAS NON-MEDTRONIC. ON 2022-FEB-09, RECEIVED ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575878 ↗
• InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS-DEGENERATIVE LUMBAR SCOLIOSIS INVOLVED IN THE POSTERIOR SPINAL FUSION (PSF) AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. LEVELS IMPLANTED- T9-S2AI. IT WAS REPORTED THAT DURING USE, ROD WAS BROKEN AT T11/12, L4/5, L5/S ONLY ON THE LEFT SIDE. PRODUCTS WERE USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO BROKEN FRAGMENTS LEFT IN THE PATIENT'S BODY. ADDITIONAL SURGERY- REPLACEMENT AND REINFORCEMENT DUE TO ROD BREAKAGE WAS PERFORMED. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. IT SEEMED THAT THE PATIENT COULD NOT VISIT THE HOSPITAL FOR ABOUT 5 YEARS, AND IT WAS UNKNOWN WHEN THE ROD BROKE. THERE WERE 3 BREAKS ON THE LEFT SIDE. THE VIEW WAS THAT THE ROD OF L5/S PROBABLY BROKE AND SUSPECTED THAT THE ROD OF L4/5 BROKE DUE TO THE FRACTURE OF L4. ROD BROKE ONLY ON THE LEFT SIDE BUT THE NUT ON THE RIGHT SIDE LOOSENED. PATIENT MEDICAL HISTORY: HT, CARDIAC DISORDER INITIAL SURGERY DETAIL- T9-S2AI: PSF AND L2/3/4/5/S: TLIF. SO56. CAGE WAS NON-MEDTRONIC. ON 2022-FEB-09, RECEIVED ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575863 ↗
• MalfunctionNov 19, 2020No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT DEMOGRAPHICS: INITIALS- N.S., GENDER- FEMALE, (B)(6), DOB (B)(6). PATIENT MEDICAL HISTORY: INTEGRATION DISORDER SYNDROME PRE OP DIAGNOSIS: ROD BROKEN AND SCREW BACK-OUT PROCEDURE PERFORMED: FIXATION IMPLANT DATE:(B)(6) 2018. EXPLANT DATE: (B)(6) 2020. DEVICE STATUS: EXPLANTED COMPLETELY. INITIAL SURGERY DETAILS: PRE OP DIAGNOSIS: L4 COMPRESSION FRACTURE PROCEDURE PERFORMED: T9/IL POSTERIOR FIXATION, L4 ANTERIOR SUBTOTAL REMOVAL AND PLACEMENT OF T2 IT WAS REPORTED THAT POST OP, THE RIGHT ROD BROKE OFF AND THE PLUG ON THE LEFT SIDE OF S2AI BACKED OUT. DUE TO THIS PATIENT SUFFERED LOWER BACK PAIN. AS A RESULT OF THIS REVISION SURGERY WAS PERFORMED FOR MALFUNCTION. THE FIXATION WAS PERFORMED FROM THE POSTERIOR SIDE, AND THE PLUG AND THE ROD WERE REMOVED. THE LEFT BA THAT BACKED OUT WAS REMOVED AND REPLACED WITH F9.5/70MM, AND F6.5/40MM WAS INSERTED TO THE L4 RIGHT, AND CONNECTION WAS PERFORMED AGAIN WITH THE F6.0COCR ROD. GC WAS PLACED AT L4. THE GC AT T11/12 WAS ONLY REMOVED AND NOT REINSERTED. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE. PATIENT WAS HOSPITALIZED. THE LEFT S2AI SET SCREW BACKING OUT WAS NOT NOTICED IN THE IMAGE, BUT IT WAS NOTICED DURING THE OPE

  Patient problems: Pain

  MAUDE report 10866743 ↗
• MalfunctionSep 8, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A ROD AND SCREW FOR A TLIF (L4/5,L5/S)+ PSF (L3/4). IT WAS REPORTED THAT THE ROD BETWEEN RIGHT L5 AND S BROKE. THE ROD BROKE AND THERE WAS NO FRAGMENT OF THE ROD REMAINING IN THE PATIENT'S BODY. THE NUTS AT LEFT L3, S1 AND S2AI BACKED OUT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS PROTRACTED BONE FUSION. THE LEVELS IMPLANTED WERE L3-S2AI. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME/ IN- PATIENT OR PROLONGATION OF EXISTING HOSPITALIZATION. ADDITIONAL SURGERY WAS PERFORMED AS REPLACEMENT OF ROD WAS PERFORMED, AND THE ROD WAS REINFORCED. DATE OF INITIAL SURGERY WAS (B)(6) 2018. THE MDT PRODUCTS USED IN INITIAL SURGERY WERE SO56+GC. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ALL PRODUCTS WERE EXPLANTED. ALL PRODUCTS WERE REPLACED BY MEDTRONIC PRODUCTS. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

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

  MAUDE report 10501149 ↗