CD Horizon® Spinal System 7078397Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20643169210190), received between Apr 6, 2022 and Aug 29, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR BILATERAL ROD BREAKAGE, SET SCREW DISLODGEMENT OF LEFT SAI SCREW, AND ROD DISLODGEMENT ON RIGHT SAI SCREW. IT WAS REPORTED THAT THE SET SCREW OF THE LEFT SAI WAS DISPLACED, ROD DEVIATED FROM THE SCREW HEAD AND THE ROD BROKE OFF BILATERALLY UNDER L2. THE SET SCREW OF THE LEFT SAI WAS DISPLACED AND REOPERATION WAS PERFORMED ON THE RIGHT SAI. THE LEFT SAI SCREW WAS REPLACED AND AN ILIAC SCREW WAS ADDED ON BOTH SIDES. FOUR RODS WERE USED WITH MRC CONNECTORS FOR FIXATION. THE T9 BILATERAL HOOKS AND T10 BILATERAL PS THAT HAD BEEN INITIALLY FIXED WERE REMOVED. 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 17639429 ↗
• InjuryAug 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED: T10/S2 IT WAS REPORTED THAT THE SET SCREW USED IN THE INTIAL SURGERY (S2PSF) DISLODGED ON BOTH SIDES. REINFORCEMENT WAS PERFORMED BY REPLACING THE SET SCREWS ON BOTH SIDES, ADDING LSTI, AND USING DOMINOES. 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 17582878 ↗
• InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L5/S FUSION F AILURE. IT WAS REPORTED THAT PATIENT HAD  S 1SCREW REMOVAL S2AI SCREW REPLACEMENT DUE TO S1 SCREW LOOSENING S2AI SET SCREW DISLOCATION. PATIENT HAD L5/S FUSION FAILURE DUE TO SCREW LOOSENING AND DISLOCATION. THERE WAS NO PATIENT SYMPTOM REPORTED AFTER REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16929039 ↗
• InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L5/S FUSION F AILURE. IT WAS REPORTED THAT PATIENT HAD  S 1SCREW REMOVAL S2AI SCREW REPLACEMENT DUE TO S1 SCREW LOOSENING S2AI SET SCREW DISLOCATION. PATIENT HAD L5/S FUSION FAILURE DUE TO SCREW LOOSENING AND DISLOCATION. THERE WAS NO PATIENT SYMPTOM REPORTED AFTER REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16929034 ↗
• InjuryApr 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT THE INITIAL SURGERY OF POSTERIOR THORACOLUMBAR SPINAL FUSION (TH11-IL), PLIF (L4/L5/S1) WAS PERFORMED ON (B)(6) 2021. THE IL SCREW AND LATERAL CONNECTOR HAD BECOME LOOSE AND AN ADDITIONAL SURGERY WAS PERFORMED TO RE-INSERT THE SCREW AND RE-TIGHTEN THE ROD AND CONNECTOR. THE PRODUCTS HAVE BEEN EXPLANTED AND DISCARDED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021 AND THE PATIENT WAS IMPLANTED WITH SET SCREWS AND CONNECTORS. ON (B)(6) 2023, A REPEAT SURGERY WAS PERFORMED TO TREAT THE CONNECTOR THAT HAD BEEN DISCONNECTED DUE TO LOOSE SET SCREWS IN THE IL SCREW. THE PRODUCTS WAS REMOVED AND REPLACED WITH NEW SCREW AND CONNECTOR. ON (B)(6) 2023, ANOTHER REPEAT SURGERY WAS PERFORMED TO TREAT THE DISCONNECTION OF THE IMPLANTED CONNECTOR DUE TO LOOSENING OF THE IL SET SCREW. THERE WAS NO ALLEGATION AGAINST THE THREE REPORTED CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766891 ↗
• InjuryApr 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT THE INITIAL SURGERY OF POSTERIOR THORACOLUMBAR SPINAL FUSION (TH11-IL), PLIF (L4/L5/S1) WAS PERFORMED ON (B)(6) 2021. THE IL SCREW AND LATERAL CONNECTOR HAD BECOME LOOSE AND AN ADDITIONAL SURGERY WAS PERFORMED TO RE-INSERT THE SCREW AND RE-TIGHTEN THE ROD AND CONNECTOR. THE PRODUCTS HAVE BEEN EXPLANTED AND DISCARDED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021 AND THE PATIENT WAS IMPLANTED WITH SET SCREWS AND CONNECTORS. ON (B)(6) 2023, A REPEAT SURGERY WAS PERFORMED TO TREAT THE CONNECTOR THAT HAD BEEN DISCONNECTED DUE TO LOOSE SET SCREWS IN THE IL SCREW. THE PRODUCTS WAS REMOVED AND REPLACED WITH NEW SCREW AND CONNECTOR. ON (B)(6) 2023, ANOTHER REPEAT SURGERY WAS PERFORMED TO TREAT THE DISCONNECTION OF THE IMPLANTED CONNECTOR DUE TO LOOSENING OF THE IL SET SCREW. THERE WAS NO ALLEGATION AGAINST THE THREE REPORTED CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766886 ↗
• InjuryApr 6, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD AND SCREWS IMPLANTED IN A PATIENT. PROCEDURE PERFORMED IN THE INITIAL SURGERY WAS T9/S2 WAS FIXATED WITH PSF FROM DEGENERATIVE KYPHOSCOLIOSIS. PRE-OP DIAGNOSIS FOR THE REVISION SURGERY WAS BROKEN ROD, SAI SET SCREW DISLODGEMENT ON BOTH SIDES, BILATERAL S1 SCREW AND LEFT SAI SCREW LOOSENING. PROCEDURE PERFORMED IN REVISION SURGERY WAS BOTH SIDES OF S1 SCREWS AND THE LEFT SAI SCREW WERE REPLACED. IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021, BUT DUE TO THE BROKEN ROD, REOPERATION WAS PERFORMED ON (B)(6) 2021. A REOPERATION WAS PERFORMED BECAUSE THE ROD WAS BROKEN AGAIN, THE SET SCREW USED FOR THE SAI SCREW CAME OFF, AND THE SCREW BECAME LOOSE. THE PHYSICIAN REQUESTED THAT THE SCREW HEAD OF THE SAI SCREW THREAD BE CHECKED FOR DAMAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024936 ↗
• InjuryApr 6, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD AND SCREWS IMPLANTED IN A PATIENT. PROCEDURE PERFORMED IN THE INITIAL SURGERY WAS T9/S2 WAS FIXATED WITH PSF FROM DEGENERATIVE KYPHOSCOLIOSIS. PRE-OP DIAGNOSIS FOR THE REVISION SURGERY WAS BROKEN ROD, SAI SET SCREW DISLODGEMENT ON BOTH SIDES, BILATERAL S1 SCREW AND LEFT SAI SCREW LOOSENING. PROCEDURE PERFORMED IN REVISION SURGERY WAS BOTH SIDES OF S1 SCREWS AND THE LEFT SAI SCREW WERE REPLACED. IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021, BUT DUE TO THE BROKEN ROD, REOPERATION WAS PERFORMED ON (B)(6) 2021. A REOPERATION WAS PERFORMED BECAUSE THE ROD WAS BROKEN AGAIN, THE SET SCREW USED FOR THE SAI SCREW CAME OFF, AND THE SCREW BECAME LOOSE. THE PHYSICIAN REQUESTED THAT THE SCREW HEAD OF THE SAI SCREW THREAD BE CHECKED FOR DAMAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024800 ↗