CD HORIZON® Spinal System 869-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074046617), received between Dec 26, 2017 and Jan 5, 2022 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJan 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T3-ILIUM POSTERIOR SPINAL FUSION DUE TO SCOLIOSIS. IT WAS REPORTED THAT ROD BROKE AFTER IMPLANTATION. ANY PATIENT COMPLICATIONS OR INJURIES ARE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167300 ↗
• InjuryApr 21, 2020Break; Inadequate or Insufficient Training; Break; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4-L5 DISC DEGENERATION WITH NARROWING OF THE CANAL AND COMPRESSION OF THE DURAL SAC. HE UNDERWENT L4-L5 DISCECTOMY WITH PLACEMENT OF TRANS-PEDICULAR SCREWS AND TITANIUM BARS. DURING THE SURGERY, THERE WAS ELIMINATION OF THE INTERVERTEBRAL DISC OF L4 AND L5 PERFORMED, AND NO BIOLOGICAL GRAFT OR INTERSOMATIC CAGE WAS PLACED TO SEEK FUSION. REPORTEDLY, DUE TO LACK OF TRAINING, THE SURGEON PERFORMED DISCECTOMY AND DID NOT PLACE INTERSOMATIC CAGE. SO, WHEN REMOVING THE DISC AND NOT PLACING THE SUPPLEMENT (SUCH AS CAGE), THE RODS AND SCREWS RECEIVED 100% OF THE AXIAL LOAD. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED ROD BROKE. ADDITIONALLY, THE PATIENT SUFFERED FROM MUSCLE SPASM, SEVERE DISABLING PAIN, PSYCHOLOGICAL STRESS AND WEIGHT GAIN FROM THE TREATMENT RECEIVED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH, REMOVAL AND REPLACEMENT OF ALL THE IMPLANTS WAS PERFORMED. ADDITIONALLY, TWO INTERSOMATIC CAGES WERE ALSO INSERTED IN THIS REVISION SURGERY. EVEN AFTER THE REVISION SURGERY, REPORTEDLY, THE PATIENT HAD A PARTIAL RECOVERY. THE PATIENT STILL HAS RADICULOPATHY AND SLEEP (NUMBNESS) IN THE LOWER EXTREMITIES.

  Patient problems: Muscle Spasm(s); Neuropathy; Pain

  MAUDE report 9980433 ↗
• MalfunctionDec 26, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: STENOSIS PROCEDURE: FUSION LEVELS: L3-L5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST -OP, ROD WAS FOUND BROKEN.THE FRAGMENTS OF THE BROKEN ROD REMAIN INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7145461 ↗