CD HORIZON® Spinal System 8115545Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00721902729713), received between Mar 24, 2017 and Nov 27, 2025 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CONVENTIONAL PO STERIOR THORACOLUMBAR SPINE SURGERY. IT WAS REPORTED THAT, DURING IMPLANTATION, WHEN TIGHTENING THE CROSSLINK AND THE CONNECTING SCREW, THE SCREW TIP FRACTURED. IT BROKE DURING THE TIGHTENING PROCESS DURING IMPLANTATION AND WAS THEREFORE REMOVED AND NOT REIMPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663942 ↗
• MalfunctionApr 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (DISTRIBUTOR, HEALTH CARE PROVIDER) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FIXATION SURGERY. LEVELS IMPLANTED WERE L3-L4. IT WAS REPORTED THAT WHILE EXAMINING THE CROSSLINK X10, THE DOCTOR ATTEMPTED TO TIGHTEN THE SET SCREW TO SECURE IT. HOWEVER, DURING THE SURGERY, THE SET SCREW BROKE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813489 ↗
• MalfunctionJul 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CROSSLINK IN A THORACOLUMBAR SPINE DEGENERATION SURGERY FOR DEGENERATION. IT WAS REPORTED THAT THE CROSSLINK SCREW PLUG WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071796 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL INTERNAL FIXATION SURGERY FOR SPINAL TUMOR. IT WAS REPORTED THAT THE CROSSLINK SCREW TIP WAS BROKEN. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752079 ↗
• MalfunctionJun 20, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL TUMOR. IT WAS REPORTED THAT, CROSSLINK-CONNECTING SCREW TIP WAS BROKEN AND PLUG SCREW WAS DETACHED. THE PROCEDURE OR TECHNIQUE PERFORMED WAS SPINAL FIXATION SURGERY. THE STATUS OF PRODUCT WAS MENTIONED AS EXPLANTED - PARTIAL. THE CONNECTING SCREW TIP WAS BROKEN FOR BOTH THE CROSS LINKS. THE SCREW TIP OF TWO PRODUCTS WERE DAMAGED. BOTH THE REPORTED CROSS LINKS CAME IN CONTACT WITH PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741897 ↗
• MalfunctionMay 27, 2022Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT POSTERIOR LUMBAR FUSION (PLF) SPINAL THERAPY FOR TRAUMA. IT WAS REPORTED THAT THE TBOLT POSITIONER NOT GRIPPING CROSSLINK AND THE SET SCREW OF CROSSLINK BROKE APART UPON FINAL TIGHTENING. NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS CAME IN CONTACT WITH THE PATIENT AND THERE WAS A DELAY OF 10 MINUTES IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520415 ↗
• MalfunctionJan 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T8-L1 OPEN THOR ACIC FUSION WITH MEDICAL HISTORY OF SULFA AND AUGMENTIN WITHOUT ANY PRE-EXISTING CONDITIONS. IT WAS REPORTED THAT WHILE TIGHTENING THE SET SCREW OF THE CROSSLINK, IT BROKE INTO TWO PIECES, LEAVING THE METAL SHAVINGS BEHIND. SO, THE CROSSLINK HAS TO BE TAKEN OFF ALONG WITH ALL THE SET SCREWS AND THE ROD FROM THE LEFT SIDE OF THE CONSTRUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13263997 ↗
• MalfunctionJun 8, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SCOLIOSIS FOR LUMBAR ARTRODESIS SPINAL THERAPY. IT WAS REPORTED THAT THE CROSSLINK BROKEN IN THE NEARBY PART AND NOT IN THE BREAK THREAD. IT WAS REPLACED AND THERE WAS NO DAMAGE TO THE PATIENT OR DAMAGE TO THE PROCEDURE. THERE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11954662 ↗
• InjuryMar 31, 2021Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE CAP WAS BROKEN. THERE WAS A DELAY OF MORE THAN 60 MINS REPORTED IN OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594007 ↗
• MalfunctionMar 18, 2021Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510419 ↗
• MalfunctionDec 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (LEVELS IMPLANTED- L4/5) DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THREE TIMES THE SURGEON TRIED TO TORQUE OFF THE SET SCREW ON THE LEFT AND EACH TIME IT SHEARED THE BOTTOM OF THE SET SCREW OFF INSTEAD OF BREAKING OFF THE TOP LIKE IT IS SUPPOSED. THE CROSSLINK DIDN'T TORQUE OUTPUT PROPERLY. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT. THE CROSSLINK WAS IMPLANTED ON (B)(6) 2020 AND WAS EXPLANTED (B)(6) 2020 ONLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940262 ↗
• MalfunctionSep 9, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH POSTERIOR LUMBAR DECOMPRESSION INVOLVED IN FUSION THERAPY. IT WAS REPORTED DURING PROCEDURE, BOTTOM OF THE LOCKING SCREW PLUG WAS BROKEN AND, IT DID NOT BREAK WHERE IT SHOULD BE BROKEN. THE DEVICE WAS REPLACED. PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE IS NO ADDITIONAL SURGERY PERFORMED. PATIENT IS ALIVE AND NO INJURY.

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

  MAUDE report 10512505 ↗
• MalfunctionSep 8, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR FIXATION AND FUSION DUE TO LUMBAR DEGENERATION. IT WAS REPORTED THAT THE CROSSLINK SCREW CAP WAS FOUND BROKEN DURING X-RAY BEFORE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND A PART OF THE SCREW CAP FELL ON THE EPIDURAL OF THE LUMBAR SPINE. THE NUT OF THE X10 CROSSLINK WAS ABNORMALLY BROKEN AND BROKE IN THE PATIENT'S BODY AFTER THE SURGERY. THE DEVICE REMAINS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10500700 ↗
• MalfunctionAug 25, 2020Failure to Align; Failure to Align

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH BURST FRACTURE OF THORACIC 12 AND COMPRESSION FRACTURE OF LUMBAR 1 FOR SPINAL THERAPY. IT WAS REPORTED THAT CROSSLINK SLIPPED AND COULDN'T BE FIXED. DEVICE EX-PLANTED AND WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446898 ↗
• MalfunctionJul 29, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR DEGENERATION FOR LUMBAR POSTERIOR INTERNAL FIXATION THERAPY. IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE CROSSLINK, THE SELF-BREAKING SCREW PLUG BROKE PREMATURELY, RESULTING IN FAILURE TO ACHIEVE THE LOCKING EFFECT. AS A RESULT, THE WHOLE PART WAS REMOVED. THE DEVICE WAS REPLACED AND WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10337156 ↗
• MalfunctionJul 29, 2020Break; Material Deformation; Break; Material Deformation

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT CROSSLINK WAS BROKEN AND THE SET SCREWS OF THE CROSSLINK WERE SHEARED OFF AND BROKEN. IT WAS MENTIONED THAT UPON TORQUING THE SET SCREW, THEY NOTICED THAT THE SET SCREW HAD BROKE AND THE BOTTOM PORTION OF THE SET SCREW WAS SHEARED OFF. THE SET SCREW WAS REPLACED AND A SECOND ATTEMPT OF TORQUING TOOK PLACE, AGAIN THE SET SCREW SHEARED OFF. LATER, THEY REMOVED ENTIRE CROSSLINK AND REPLACED A NEW CROSSLINK OF SAME SIZE AND THEN TORQUING WAS SUCCESSFUL. ALL THE BROKEN PARTS OF CROSSLINK AND SETSCREW WERE REMOVED. IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS OF IMPLANT/INSTRUMENT LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS REPORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10337130 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FIXATION AND FUSION SURGERY AT LUMBAR LEVEL DUE TO LUMBAR DEGENERATIVE. INTRA-OP, LUMBAR VERTEBRA CROSSLINK CREW NUT WAS BROKEN. NO FRAGMENT OF THE IMPLANT ARE REMAINING IN THE PATIENT BODY AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10210539 ↗
• MalfunctionJun 4, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS. SHE UNDERWENT LUMBAR SPINAL DECOMPRESSION VIA POSTERIOR L4 LAMINECTMY, L4-L5 DISCECTOMY AND POSTERIOR LATERAL BONE GRAFT FUSION WITH INTERNAL FIXATION. INTRA-OP, THE SCREW PLUG OF THE CROSSLINK SLIPPED AND COULDN'T BE FIXED. HENCE, THE CROSSLINK WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121231 ↗
• MalfunctionFeb 20, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR FUSION TECHNIQUE DUE TO LUMBAR DEGENERATIVE. INTRA-OP, THE PRODUCT WAS SLIPPERY. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9731425 ↗
• MalfunctionOct 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION DUE TO GENERATIVE DISEASE (HERNIATED NUCLEUS PULPOSES). INTRA-OP, THE CROSSLINK BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT; BUT NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9160280 ↗
• MalfunctionAug 14, 2019Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR DECOMPRESSION AND FUSION INTERNAL FIXATION AT L3-L5 DUE TO LUMBAR DEGENE RATIVE DISEASE. INTRA-OP, THE SCREW PLUG COULD NOT BE FINALLY LOCKED AND IT BROKE. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892107 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR DECOMPRESSION AND FUSION INTERNAL FIXATION AT L3-L5 DUE TO LUMBAR DEGENE RATIVE DISEASE. INTRA-OP, THE SCREW PLUG COULD NOT BE FINALLY LOCKED AND IT BROKE. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892034 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREW BROKE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW. CROSSLINK WAS ALSO EXPLANTED IN THIS REVISION SURGERY; FOR WHICH NO MALFUNCTION WAS REPORTED. NO FRAGMENTS OF THE SCREW REMAINED INSIDE THE PATIENT. THE PATIENT HAD NOT ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8324831 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L5 SPINAL REDUCTION AND INTERBODY FUSION INTERNAL FIXATION DUE TO SPONDYLOLISTHESIS OF THE L5 BILATERAL ISTHMUS AND L5-S1 LATENT FISSURE. INTRA-OP, WHEN THE DOCTOR COMPLETED THE IMPLANTATION AND LOCKED THE SCREW, THE SCREW BROKE. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE DEVICE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7572746 ↗
• MalfunctionMay 17, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT LUMBAR 4-5 SPONDYLOLISTHESIS REDUCTION,LUMBAR 5-SACRAL 1 DISCECTOMY, SPINAL CANAL DECOMPRESSION AND PEDICLE SCREW INTERNAL FIXATION DUE TO LEVEL III OF SPONDYLOLISTHESIS OF LUMBAR 5 VERTEBRAE. INTRA-OPERATIVELY, WHILE THE SURGEON WAS USING THE TOOL TO TIGHTEN THE SCREW NORMALLY, A SCREW OF THE CROSSLINK BROKE. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO FRAGMENTS OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7521610 ↗