CD HORIZON® Spinal System 7570900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994302748), received between Oct 12, 2017 and Apr 9, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VOYAGER CASE MIS LUMBAR ARTHRODESIS PROCEDURE. IT WAS REPORTED THAT THE INSERTER WAS NOT ABLE TO GRASP THE ROD AS EXPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834876 ↗
• InjuryOct 11, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD INSERTER USED ON PATIENT HAVING CASE OF THE L4-L5 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) WITH SEXTANT II THERAPY FOR L4-L5 CENTRAL STENOSIS. IT WAS REPORTED THAT IN POST OPERATIVE X-RAY SURGEON FOUND A FOREIGN BODY ON THE RIGHT SIDE NEAR THE ZIG INSERTION SITE. IT WAS UNDERSTOOD THAT IT WAS PART OF THE ROD GRIPPER OF THE ZIG. THIS WAS NOT SEEN IN PRE-OP IMAGES AS THE BROKEN PIECE WAS FAR FROM THE IMPLANTED AREA. PATIENT HAD THE REVISION SURGERY NEXT DAY FOR REMOVAL OF THE BROKEN FLANGE OF THE ZIG. THERE WERE NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426209 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR ARTHRODESIS OF 5 LEVELS. INTRA-OP, WHEN INSERTING THE FORCEPS, TIP OF THE ROD INSERTER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT; BUT NO FRAGMENT OF THE BROKEN INSERTER REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 9246175 ↗
• MalfunctionSep 10, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  SURGEON BENT THE ITEM WHEN REMOVING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8980122 ↗
• InjuryOct 12, 2017Break; Break

  PRE-OP DIAGNOSIS: NERVE COMPRESSION, LEG PAIN PROCEDURE: ROD INSERTED DURING SPONDYLODESIS. THE INSERTER WAS 'BEENACHTIG' THE SKIN AND FASCIA. LEVELS IMPLANTED: L3-L4 IT WAS REPORTED THAT INTRA-OP, THE TIP OF THE ROD INSERTER WAS REPORTED BROKEN. THE TWO PINS OFF THE INNER SLEEVE FROM THE INSERTER WERE FIXED INTO THE TULIP OF THE SCREW. WHEN THE DOCTOR TRIED TO LOOSE THE INSERTER FROM THE ROD THE TIP BROKE OFF. ONE OF THE TWO PINS GOT OUT OF THE PATIENT, THE OTHER ONE WAS STUCK BETWEEN THE ROD AND THE SCREW. THE DOCTOR ACCEPTED THIS INSTEAD OF OPENING THE SKIN AND FASCIA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE FRAGMENTS OF THE INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6943511 ↗