CD HORIZON® Spinal System 25840018590Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169413276), received between Dec 14, 2019 and May 16, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD A SCREW EXPLANT. IT WAS REPORTED THAT THE SCREW BROKE AS PATIENT TRIPPED AND FELL. THE SCREW HEAD SHEARED OFF OF THE SHAFT. THE PATIENT HAD T8/PELVIS FUSION 3 LEVEL TLIF 6.0 TI ALLOY QUAD ROD.  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 16937603 ↗
• MalfunctionJun 14, 2022Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR L2-PELVIS DUE TO A FLAT BACK. PROCEDURE OR TECHNIQUE USED WAS NORMAL USE ON A 6.0 COCR PLUS ROD. LEVELS IMPLANTED L2-PELVIS. IT WAS REPORTED THAT THE RETAINING PIN/WIRE BACKED ITSELF OUT ON INSERTION. THE DOCTOR THEN PUSHED THE WIRE BACK IN. THE SCREW WAS TOO TIGHT AND SURGEON COULDN'T GET THE SCREW TO COME OUT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE BENDER BROKE IN THE PATIENT BUT THE FRAGMENT WAS REMOVED WITH NO DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683038 ↗
• InjuryDec 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN LUMBAR FUSION AT L2-PELVIS. ON AN UNKNOWN DATE, POST-OP, SET SCREW DISLODGED FROM THE PEDICLE SCREW. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE LOOSE SCREW WAS REMOVED AND WAS REPLACED WITH BIGGER SCREW. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9470711 ↗
• InjuryDec 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN LUMBAR FUSION AT L2-PELVIS. ON AN UNKNOWN DATE, POST-OP, SET SCREW DISLODGED FROM THE PEDICLE SCREW. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE LOOSE SCREW WAS REMOVED AND WAS REPLACED WITH BIGGER SCREW. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9470709 ↗