CD HORIZON® Spinal System 8115536Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00721902729669), received between Jul 20, 2017 and Jul 2, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGRADING A PATIENT UNDERGONE THORACIC¿LUMBAR PEDICLE SCREW FIXATION FOR COMPRESSION FRACTURE OF THE 12TH THORACIC VERTEBRA (T12). LOCKING SCREW FIXING THE CROSS ROD WAS BROKEN. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. 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 25692861 ↗
• MalfunctionJul 28, 2025Break; Product Quality Problem; Material Deformation; Break; Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED CROSSLINK HAVING POSTERIOR OPEN SURGERY FOR DEGENERATIVE DISEASES. IT WAS REPORTED THAT THE IMPLANT HAD PRODUCT QUALITY PROBLEM. IMPLANT WAS FRACTURED AND ACCESSORY WAS STRIPPED. THE PRODUCT WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629714 ↗
• MalfunctionMay 1, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION FOR LUMBAR DEGENERATIVE DISEASE. IT WAS REPORTED THAT IN THE PROCESS OF USING THE CROSSLINK, WHEN ATTEMPTED TO BREAK THE CAP WHILE SCREWING IN, THE PRODUCT BROKE AND COULDN'T BE USED. NO FRAGMENT WAS LEFT IN THE PATIENT. 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 16842940 ↗
• 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 14741852 ↗
• MalfunctionMar 3, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH L1 FRACTURE FOR TRAUMA AND SPINAL FIXATION WAS MADE FROM T11 - L2, ALSO A LAMINOTOMY IN L1 LEVEL. IT WAS REPORTED THAT THE CROSSLINK WAS MEASURED, THEN THE DOCTOR REQUESTED THE IMPLANT IN SIZE 36-39 MM, UNSCREWED THE GOLD SCREWS SO THAT THE IMPLANT COULD ENTER BOTH BARS AND MADE SURE THAT THE MEASUREMENT WAS CORRECT, THEN HE FIXED THE MIDDLE SCREW AND PROCEEDED TO SCREW THE GOLD SCREW ON THE RIGHT SIDE OF THE PATIENT AND THEN ON THE LEFT SIDE WITHOUT ANY PROBLEM. AFTER THAT, THE DOCTOR ASKED FOR THE TORQUE AND ANTI-TORQUE FOR THE CROSSLINK SCREWS AND STARTED FROM THE RIGHT SIDE AND AT THE END OF THE TORQUE MOVEMENT HE SAW A SMALL PIECE OF GOLD UNDER THE CROSSLINK AND PROCEEDED TO REMOVE IT AND REALIZED THAT IT WAS THE TIP. CROSSLINK SCREW THAT FELL OFF. THEN HE PROCEEDED TO REMOVE THE BROKEN SCREW AND THE DOCTOR ASKED FOR A NEW SCREW THAT WAS TAKEN FROM ANOTHER CROSSLINK, THEN HE DID THE TORQUE AND THE SAME HAPPENED THESE LAST PART HAPPEN 3 TIMES IN TOTAL, AFTER THAT HE REMOVED THE CROSSLINK AND ASKED FOR A LARGER MEASUREMENT (45-58), START THE IMPLANT PROCEDURE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403252 ↗
• MalfunctionOct 20, 2020Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF SPONDYLOLISTHESIS INVOLVED IN POSTERIOR LUMBAR 4 LAMINECTOMY, LUMBAR 45 DISCECTOMY, SPINAL CANAL DECOMPRESSION, NERVE ROOT LYSIS, LUMBAR 4 SPONDYLOLISTHESIS OPEN REDUCTION, LUMBAR 45 INTERVERTEBRAL AND POSTEROLATERAL BONE GRAFTING, PEDICLE SCREW INTERNAL FIXATION USED IN SPINAL THERAPY. IT WAS REPORTED DURING INTRA-OP, INSTRUMENT SLIPPED AND COULD NOT BE FIXED. PRODUCT CAME IN CONTACT WITH PATIENT. THERE IS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. INSTRUMENT DID NOT BREAK AND NO FRAGMENT LEFT IN THE PATIENT. THERE IS NO ADDITIONAL SURGERY PERFORMED. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10706125 ↗
• MalfunctionMar 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH TUMOR; AND UNDERWENT POSTERIOR LUMBAR FUSION. INTRA-OP, THE CROSSLINK BROKE. NO FRAGMENT OF THE BROKEN CROSSLINK 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 9861105 ↗
• MalfunctionFeb 3, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR DISC HERNIATION. AFTER POSTERIOR L3-L5 LAMINECTOMY, SPINAL CANAL DECOMPRESSION, L3-S1 DISCECTOMY, BILATERAL NERVE ROOT RELEASE, BONE GRAFT AND POSTEROLATERAL FUSION FROM BODY BONE AND ARTIFICIAL BONE WAS PERFORMED. INTRA-OP, SCREW OF THE CROSSLINK BROKE. THE BROKEN IMPLANT WAS EXPLANTED COMPLETELY; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9662140 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING LUMBAR FUSION. INTRA-OP, THE SCREW PLUG OF THE CROSSLINK BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN CROSSLINK REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564580 ↗
• MalfunctionMay 30, 2018Failure to Align; Failure to Align

  TYPE OF PROCEDURE OR TECHNIQUE USED: LUMBAR FUSION PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DEFORMITY IT WAS REPORTED THAT INTRA-OP, THE DRIVER CAUSED CROSSLINK CENTER NUT TO STRIP. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555273 ↗
• MalfunctionMar 21, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINE DISEASE AND UNDERWENT SPINE SURGERY. DURING SURGERY, THE PRODUCT BROKE. NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7356512 ↗
• 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 6727314 ↗