CD HORIZON® Spinal System 25840018580Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169413269), received between Feb 27, 2018 and Nov 12, 2024 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 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.

• MalfunctionNov 12, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENTS BONE WAS VERY STRONG AND WHILE PUTTING IN THE SCREW ON POWER THE SCREW WAS UNABLE TO ADVANCE FURTHER. WHEN SURGEON TRIED TO BACK OUT THE SCREW THE SCREW WAS UNABLE TO BACK OUT. AND THE THREADING AROUND THE TULIP HEAD OF THE SCREW WAS BEGINNING TO BREAK. EVENTUALLY THE SCREW HEAD CAME OFF AND THE SHANK WAS LEFT IN THE PATIENT AFTER NUMEROUS EFFORTS WITH USR. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20662084 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS BACK PAIN. IT WAS REPORTED THAT, THE SET SCREW ON ONE SIDE CAME LOOSE. THE OTHER SIDE THE RODS CAME OUT OF TULIP WITH SET SCREW STILL IN PLACE. BOTH RODS SLID CRANIAL OUT OF THE TULIPS OF THE BALLAST SCREWS. NO ALLEGATIONS ON THE ROD. PROCEDURE OR TECHNIQUE PERFORMED WAS T10-ILLIUM POSTERIOR FUSION. PATIENT EXPERIENCED PAIN WHILE STANDING. THERE IS A REVISION SURGERY IN PLAN. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 20382197 ↗
• InjuryJul 27, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SCOLIOSIS AT T10- PELVIS FOR SPINAL THERAPY. IT WAS REPORTED THAT SET SCREWS POPPED OFF OR LET THE ROD SLIP OUT. THERE WAS A REVISION SURGERY THAT WAS REQUIRED TO PLACE NEW IMPLANTS THAT LASTED 4 HOURS AS A RESULT OF THIS EVENT. IT WAS UNKNOWN WHICH SCREW POPPED OFF AND SURGEON REMOVED ALL THE SCREW IN PILE TOGETHER. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230613 ↗
• InjuryJul 27, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SCOLIOSIS AT T10- PELVIS FOR SPINAL THERAPY. IT WAS REPORTED THAT SET SCREWS POPPED OFF OR LET THE ROD SLIP OUT. THERE WAS A REVISION SURGERY THAT WAS REQUIRED TO PLACE NEW IMPLANTS THAT LASTED 4 HOURS AS A RESULT OF THIS EVENT. IT WAS UNKNOWN WHICH SCREW POPPED OFF AND SURGEON REMOVED ALL THE SCREW IN PILE TOGETHER. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230568 ↗
• InjuryMar 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE OSTEOMYELITIS OF T10, T11 AND T12. SHE UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW BROKE AT S2-ALAR. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY AND THE BROKEN SCREW WAS EXPLANTED. THE PATIENT ALSO HAD DIFFICULTY WALKING DUE TO LOWER EXTREMITIES, MULTILEVEL NON-UNIONS, SPINS OSTEOMYELITIS.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 9803598 ↗
• InjuryMar 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE OSTEOMYELITIS OF T10, T11 AND T12. SHE UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW BROKE AT S2-ALAR. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY AND THE BROKEN SCREW WAS EXPLANTED. THE PATIENT ALSO HAD DIFFICULTY WALKING DUE TO LOWER EXTREMITIES, MULTILEVEL NON-UNIONS, SPINS OSTEOMYELITIS.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 9803597 ↗
• InjuryMar 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL STENOSIS OF THORACIC REGION; AND UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE S2-ALAR SCREW BROKE. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. THIS SCREW WAS THEN DISPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803586 ↗
• InjuryMar 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL STENOSIS OF THORACIC REGION; AND UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE S2-ALAR SCREW BROKE. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. THIS SCREW WAS THEN DISPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803583 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLAST SCREWS PLACED IN S2 ALAR DUE TO LUMBAR STENOSIS WITH NEUROLOGICAL CLAUDICATION, DEGENERATIVE FLATBACK, DEGENERATIVE SCOLIOSIS. POST-OP, THE IMPLANT BROKE. HENCE ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN IMPLANTS. NO FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9796208 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLAST SCREWS PLACED IN S2 ALAR DUE TO LUMBAR STENOSIS WITH NEUROLOGICAL CLAUDICATION, DEGENERATIVE FLATBACK, DEGENERATIVE SCOLIOSIS. POST-OP, THE IMPLANT BROKE. HENCE ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN IMPLANTS. NO FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9796201 ↗
• MalfunctionMar 2, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS SURGERY IN S2 ALAR DUE TO CHRONIC BILATERAL LOWER BACK PAIN WITH BILATERAL SCIATICA, THORACIC MYELOPATHY, DEGENERATIVE FLATBACK SYNDROME, MR SPINAL STENOSIS. POST-OP, THE SET SCREW KICKED OUT. NO REVISION PLANED SO FAR FOR THE CORRECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9773167 ↗
• MalfunctionMar 2, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS SURGERY IN S2 ALAR DUE TO CHRONIC BILATERAL LOWER BACK PAIN WITH BILATERAL SCIATICA, THORACIC MYELOPATHY, DEGENERATIVE FLATBACK SYNDROME, MR SPINAL STENOSIS. POST-OP, THE SET SCREW KICKED OUT. NO REVISION PLANED SO FAR FOR THE CORRECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9773156 ↗
• InjuryNov 6, 2019Migration; Migration

  IT WAS REPORTED THAT POST-OP, THE IMPLANTED DEVICE HAS BEEN BACKED OUT. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT FOR THE REMOVAL OF THE ALLEGED DEVICE. AFTER THE REVISION SURGERY PATIENT IS DOING WELL DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9283689 ↗
• MalfunctionFeb 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT, POST-OP, FRACTURE OF THE SCREW WAS OBSERVED AT SI JOINT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7300386 ↗