CD HORIZON® Spinal System 8115539Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00721902729690), received between Jul 20, 2017 and May 3, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP)/ OTHER VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CROSSLINK IN AN OPEN SCREW REVISION+ VERTEBRAL RECONSTRUCTION FOR A POSTOPERATIVE REVISION OF THORACIC SPINE FRACTURES. IT WAS REPORTED THAT THE CROSSLINK'S LOCKING SCREW NUT WAS BROKEN. THE CROSSLINK WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236585 ↗
• MalfunctionNov 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CROSSLINK IN A LUMBAR INTERNAL FIXATION SURGERY FOR A LUMBAR DEGENERATION. IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW PLUG OF THE CROSSLINK WAS BROKEN IN ADVANCE. IT WAS COMPLETELY TAKEN OUT AND NO DEBRIS REMAINED. THE CROSSLINK WAS REMOVED COMPLETELY AFTER IMPLANTATION. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859070 ↗
• MalfunctionOct 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH T1 TUMOR FOR POST ERIOR STABILIZATION AT C5-6, T2-3 FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW OF CROSSLINK BROKE IN ONE SIDE ONLY, BUT IN OTHER SIDE SET SCREW STILL CAN BE TIGHTENED. PART / FRAGMENT OF THE THREAD OF SET SCREW STILL REMAIN IN THE CROSSLINK THAT IMPLANTED TO THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12679533 ↗
• MalfunctionJun 1, 2021Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF DEGENERATIVE SCOLIOSIS INVOLVED IN POSTERIOR LUMBAR 3 SPINAL CANAL DECOMPRESSION, SPINAL NERVE LYSIS, BONE GRAFT FUSION AND FIXATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, SCREW PLUG SLIPPED AND COULD NOT FIX. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. EVENT WAS ASSOCIATED WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912523 ↗
• MalfunctionFeb 22, 2021Break; Break

  INFORMATION WAS RECEIVED A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF DEGENERATIVE DISEASE IN NEED OF LUMBAR REVISION SURGERY USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN IMPLANTED THE CROSSLINK IN THE PATIENT'S BODY, THE SCREW PLUG BROKE, AND THE DOCTOR IMMEDIATELY TOOK OUT THE BROKEN CROSSLINK WITHOUT CAUSING ANY DAMAGE TO THE PATIENT. THE PATIENT HAS RECOVERED AND DISCHARGED. THERE WAS NO DELAY REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356926 ↗
• MalfunctionJul 6, 2020Break; Device Slipped; Connection Problem; Break; Device Slipped; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING PROCEDURE , CROSSLINK PLATE BREAK. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH EVENT. PRODUCT IS EXPLANTED. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231298 ↗
• MalfunctionJun 4, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT, INTRA-OP, THE SCREW OF THE CROSSLINK SLIPPED WHEN IT WAS SCREWED IN, SO IT COULD NOT BE SCREWED IN OR FIXED. IT WAS REMOVED INTRA-OPERATIVELY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10117582 ↗
• MalfunctionDec 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4-L5 LUMBAR DISC HERNIATION WITH SPINAL STENOSIS. SHE UNDERWENT L4 POSTERIOR LUMBAR LAMINECTOMY, DECOMPRESSION OF SPINAL CANAL, NERVE ROOT RELEASE, L4-L5 LUMBAR DISCECTOMY AND PEDICLE SCREW INTERNAL FIXATION. INTRA-OP, THE CROSSLINK BROKE. NO FRAGMENT OF THE BROKEN CROSSLINK REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527322 ↗
• MalfunctionApr 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CLASSIC OSTEOSYNTHESIS PROCEDURE FROM T5 TO T9 DUE TO FRACTURE AT T7. INTRA-OP, AT THE END OF SURGERY, WHILE PERFORMING THE FINAL TIGHTENING, THE EXTREMITY PORTION OF THE IMPLANT BROKE. THE BROKEN IMPLANT HAS BEEN REMOVED FROM THE PATIENT'S BODY. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8530380 ↗
• MalfunctionJun 28, 2018Break; Break

  PRE-OP DIAGNOSIS: LUMBAR SPINAL STENOSIS PROCEDURE: POSTERIOR DECOMPRESSION OF THE CERVICAL SPINE IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, IN THE X10 CROSSLINK, THE SCREW WAS BROKEN DURING THE IMPLANTATION, AND COULD NOT BE USED, IT WAS EXPLANTED IMMEDIATELY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7644529 ↗
• MalfunctionMar 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH 1) LUMBAR 5 SPONDYLOLYSIS. 2) L3 -L4 VERTEBRAL ENDPLATE INFLAMMATION. 3) LUMBAR 3, 4, 5 SACRAL VERTEBRAL DISC HERNIATION ON AND UNDERWENT PEDICLE SCREW FIXATION. INTRA-OP, WHEN THE DOCTOR WAS TIGHTENING THE SCREW OF THE CROSS-LINK, IT BROKE. THE DOCTOR HEARD THE BROKEN SOUND WHEN HE USED A SCREW DRIVER TO LOCK, AND FELT THE SCREW WAS NO LONGER ROTATING. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364874 ↗
• MalfunctionMar 8, 2018Break; Failure to Align; Material Deformation; Break; Failure to Align; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: LUMBAR DEGENERATIVE IT WAS REPORTED THAT INTRA-OP, LOCKING SCREW OF THE CROSSLINK SLIPPED. THE SCREW WAS IMPLANTED IN HALF WHEN IT WAS DAMAGED. PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322920 ↗
• MalfunctionAug 28, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR PROCEDURE: LUMBAR SPINAL STENOSIS IT WAS REPORTED THAT DURING SURGERY, THE NUT OF THE CROSSLINK RUPTURED. THE PRODUCT BROKE AND NO FRAGMENT REMAINED IN THE PATIENT. THE PRODUCT WAS REPLACED AND THE SURGERY COMPLETED WITHOUT ANY COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6823334 ↗
• MalfunctionJul 20, 2017Break; Break

  PROCEDURE: TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT DURING SURGERY, THE DEVICE BROKE. NO FRAGMENTS REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727315 ↗