CD HORIZON® Spinal System 8690024Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994161598), received between Aug 14, 2017 and Dec 10, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL DEFORMITY CORRECTION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD DISLODGE, BOP FAILURE, REQUIRES REVISION SPINE SURGERY TO REFIX THE DISLODGE ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. SURGERY HAPPENED ON (B)(6) 2020 BUT WHEN EXACTLY DISLODGEMENT OF ROD HAPPENED, THAT IS DIFFICULT TO COMMENT. PATIENT WENT FOR THE X-RAY, REALIZED THAT ROD HAS CAME OUT SO EXACT DATE OF THE EVENT WILL NOT BE ABLE TO GET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981436 ↗
• InjuryJun 10, 2020Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ADULT DEFORMITY WITH BOTH CORONAL AND SAGGITAL PLANE IMBALANCE, MULTILEVEL SPINAL STENOSIS AND L5 RADICULOPATHY WITH WEAKNESS AND NEUROGENIC CLAUDICATION. HE UNDERWENT T11-PELVIS FUSION. ON AN UNKNOWN DATE, POST-OP, SCRAPING HAD OCCURRED ON NUMEROUS POINTS OF THE ROD. TWO SET SCREWS WERE ALSO FOUND LOOSENED AND DISLODGED. ADDITIONALLY, THERE WAS METALLOSIS AROUND THE TREATED SITE AND PSEUDOARTHROSIS AT T11-T12 WAS ALSO REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH PARTIAL REMOVAL OF ROD WAS PERFORMED. A SECTION OF THE ALLEGED ROD WAS CUT AND REMOVED FOR THE REVISION/EXTENSION OF FUSION FROM T4 TO T11, WHICH WAS PERFORMED AS A RESULT OF PROXIMAL JUNCTIONAL KYPHOSIS AND JUNCTIONAL FAILURE OF T11. OTHER HARDWARE (SCREW AND SET SCREWS) WERE COMPLETELY EXPLANTED AND WERE REPLACED WITH NEW ONES.

  Patient problems: Failure of Implant

  MAUDE report 10140811 ↗
• InjuryJan 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SCOLIOSIS WITH MULTILEVEL STENOSIS, DEGENERATIVE DISC DISEASE (DDD) AND UNDERWENT MULTILEVEL LAMINECTOMY FUSION SURGERY AT T11- ILEUM LEVELS. POST-OPERATIVELY, THE ROD BROKE. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO REMOVE THE ALLEGED ROD. NO PATIENT COMPLICATIONS WERE REPORTED POST SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8255703 ↗
• InjuryDec 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T10 FRACTURE-THORACIC KYPHOSIS AND UNDERWENT ARTHRODESIS AT T3-S1. POST-OP, THE ROD SLIPPED OUTSIDE THE CONNECTOR MAKING FUSION IMPOSSIBLE. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8144602 ↗
• InjuryDec 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T10 FRACTURE-THORACIC KYPHOSIS AND UNDERWENT ARTHRODESIS AT T3-S1. POST-OP, THE ROD BROKE INTO THE CONNECTOR PREVENTING FUSION. AS A RESULT, PATIENT SUFFERED FROM PAIN. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8144600 ↗
• InjurySep 11, 2018Break; Break

  IT WAS REPORTED VIA A PATIENT CALL THAT ON (B)(6) 2011, PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING COBALT RODS. IN (B)(6) 2017, THE PATIENT WAS GETTING OUT OF BED AND HAD EXCRUCIATING PAIN SHOOT UP HER BACK. SHE CONTINUED TO STAY IN PAIN. SHE WENT TO THE DOCTOR ON (B)(6) 2018 AND THE AN X-RAY EXAM WAS DONE. ONE OF THE RODS WAS FOUND BROKEN IN HER BACK. IN (B)(6) THE 2ND ROD WAS ALSO FOUND TO HAVE BROKEN AND PROTRUDED THROUGH HER BACK. ON (B)(6) 2018, THE SURGEON WENT BACK IN AND DID A 2ND SURGERY. PATIENT STAYS IN PAIN AND HAD 2 SURGERIES AS A RESULT OF THE ROD BREAKAGE. NO OTHER INFO WAS AVAILABLE.

  Patient problems: Pain

  MAUDE report 7863634 ↗
• InjuryOct 26, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR INSTRUMENTATION AT T8-L5. POST-OP, THE ROD BREAKAGE WAS OBSERVED ON (B)(6) VERY CLOSE TO L4-5 AND S1. HENCE, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN ROD AND THEN DOUBLE TITANIUM ROD WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6979051 ↗
• InjuryOct 18, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR INSTRUMENTATION AT T8-L5. POST-OP, THE ROD BREAKAGE WAS OBSERVED ON (B)(6) 2017. HENCE, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN ROD AND THEN DOUBLE TITANIUM ROD WAS IMPLANTED. ACCORDING TO THE DOCTOR'S OPINION, DURING PROCEDURE WHILE BENDING ROD, ASSISTANT BENT THE ROD MORE THAN NORMAL. SO IT MIGHT BE POSSIBLE THAT DURING IMPLANTATION AND BENDING, THE ROD ALREADY CRACKED (MICRO CRACK MAYBE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6957319 ↗
• InjuryAug 14, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT PLACEMENT OF TRANSPEDICULAR INSTRUMENTATION AS WELL AS EXPLORATION OF POSTERIOR SPINAL FUSION FROM T10 TO S1. INTRA-OP FINDINGS: THE PATIENT HAD A SOLID ON LAY POSTERIOR FUSION FROMT12 TO L2. HE ALSO HAD OBTAINED AUTO-FUSION AT L4-5 AND L5-S1 THROUGH FACER JOINTS AT THESE 2 LEVELS. THERE WERE MOBILE JOINTS NOTED AT T10-11, T11-12, L2-3 AND L3-4. THE PATIENT KYPHOTIC DEFORMITY WAS CORRECTED THROUGH L1 PEDICLE SUBTRACTION OSTEOTOMY. THE L2-3 DISK WAS NOTED TO BE VERY DEGENERATED AND DEDICATED. THERE WAS TIGHT L2-3 FORAMINAL STENOSIS, WHICH WAS RELIEVED BY BILATERAL L2-3 FACETECTOMIES. THE PATIENT HAD REASONABLY GOOD BONE QUALITY. ALL SCREW PASSED TESTING AT LEAST 20MA. AS PER OPERATIVE NOTES, A 12 X 26 MM TRIAL WAS TAPPED INTO THE DISK SPACE AND FELT TO BE TIGHT. THE TRIAL WAS REMOVED USING A SLAP HAMMER. A 12 X 26 MM PEEK INTERBODY DEVICE WAS FILLED WITH LOCAL BONE AUTOGRAFT AND THEN TAPPED AND COUNTERSUNK INTO THE RIGHT SIDE /CENTRAL ASPECT OF THE DISK SPACE. THE INSERTER WAS REMOVED FROM THE PEEK INTERBODY GRAFT, AND THE INTERBODY GRAFT WAS LEFT IN PLACE. THE GRAFT APPEARED TO BE WELL COUNTERSUNK AND TIGHT WITHIN THE INTERS

  Patient problems: Ambulation or Postural Difficulties; Neuropathy; Pain

  MAUDE report 6790991 ↗