CD HORIZON® Spinal System 1476000500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994579522), received between Dec 12, 2018 and Jan 2, 2024 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2024Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST DEF ORMITY CORRECTION PROCEDURE IN A PATIENT DIAGNOSED WITH SPINAL DEFORMITY. IT WAS REPORTED THAT PATIENT HAD PAIN DUE TO ROD BREAKAGE. ROD WAS EXPLANTED. MULTIPLE CASES OF ROD BREAKAGE WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 18433014 ↗
• InjuryAug 14, 2023Break; Break

  PRE-OP DIAGNOSIS- THORACOLUMBAR KYPHOSCOLIOSIS.

  Patient problems: Pain

  MAUDE report 17538364 ↗
• InjuryApr 17, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ROD REMOVAL & EXCHANGE FOR SCOLIOSIS CORRECTION WITH BROKEN ROD. IT WAS REPORTED THAT THE ROD BROKE POSTOPERATIVELY. THERE WERE PAIN ON PATIENT WHILE LYING DOWN. ADDITIONAL SURGERY PERFORMED TO REMOVE THE ROD AND EXCHANGE. THE EXPLANTED PRODUCT WILL BE RETURNED.

  Patient problems: Pain

  MAUDE report 16749227 ↗
• InjuryApr 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A TL OPEN PROCE DURE. IT WAS REPORTED THAT THE RODS BROKE AND THE PATIENT EXPERIENCED LOW BACK PAIN WITH SWELLING OVER HIS BACK. AN ADDITIONAL SURGERY WAS PERFORMED FOR THE BILATERAL ROD EXCHANGE. NO FRAGMENT WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16705789 ↗
• InjuryNov 11, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS DEFORMITY INVOLVED IN THE CORRECTION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, ROD BROKE, AND NO FRAGMENT LEFT IN THE PATIENT BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PATIENT IS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT LEVELS TREATED/IMPLANTED- MULTI LEVEL. ROD POPPED OUT & VISIBLE FROM OUTSIDE THE SKIN. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT PAIN WAS REPORTED IN THE PATIENT DUE TO ROD POPPED OUT.

  Patient problems: Pain

  MAUDE report 12793275 ↗
• InjuryJan 31, 2019Break; Break

  PRE-OP DIAGNOSIS: INSTABILITY TYPE OF PROCEDURE: FUSION LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE RODS ON BOTH SIDES BROKE AFTER ONE YEAR OF FUSION. THE PATIENT ALSO EXPERIENCED BACK PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED WHEREIN THE BROKEN RODS WERE EXPLANTED. THE BROKEN RODS WERE REPLACED WITH RODS FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN RODS REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 8291905 ↗
• InjuryJan 31, 2019Break; Break

  PRE-OP DIAGNOSIS: INSTABILITY TYPE OF PROCEDURE: FUSION LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE RODS ON BOTH SIDES BROKE AFTER ONE YEAR OF FUSION. THE PATIENT ALSO EXPERIENCED BACK PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED WHEREIN THE BROKEN RODS WERE EXPLANTED. THE BROKEN RODS WERE REPLACED WITH RODS FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN RODS REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 8291894 ↗
• InjuryJan 31, 2019Break; Break

  PRE-OP DIAGNOSIS: INSTABILITY TYPE OF PROCEDURE: FUSION LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE RODS ON BOTH SIDES BROKE AFTER ONE YEAR OF FUSION. THE PATIENT ALSO EXPERIENCED BACK PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED WHEREIN THE BROKEN RODS WERE EXPLANTED. THE BROKEN RODS WERE REPLACED WITH RODS FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN RODS REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 8291890 ↗
• InjuryDec 12, 2018Break; Break

  PRE-OP DIAGNOSIS: INSTABILITY TYPE OF PROCEDURE: FUSION LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE AFTER ONE YEAR OF FUSION. THE PATIENT ALSO EXPERIENCED BACK PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED WHEREIN THE BROKEN ROD WAS EXPLANTED. THE BROKEN ROD WAS REPLACED WITH ROD FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN ROD REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 8154379 ↗

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