CD HORIZON® Spinal System 5442138Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994588463), received between Dec 8, 2019 and Aug 28, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K091974); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS-AIS NEUROFIBROMA INVOLVED IN THE NAVIGATE LOWER SCOLIOSIS SURGERY. IT WAS REPORTED THAT INTRA-OPERATIVELY, CAP WAS FRACTURED. PRODUCT BROKE AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE LEVEL OF TREATMENT OR IMPLANTATION WAS VERY HIGH, THE SURGEON OFTEN USED THE CROSSLINK DURING THE OPERATION, AND THE USE OF THE CROSSLINK WAS VERY FAST. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381162 ↗
• MalfunctionMar 15, 2021Break; Device Slipped; Break; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH PRE-OP DIAGNOSIS OF LUMBAR 1 CONE FRACTURE, SEVERE OSTEOPOROSIS, ANKYLOSING SPONDYLITIS. IT WAS REPORTED THAT DURING THORACOLUMBAR POSTERIOR DEVELOPMENTAL SURGERY WHEN THE PRODUCT WAS IMPLANTED, THE SCREW CAP BROKE JUST WITH LIGHT FORCE AND THE CROSSLINK SCREW CAP SLIPPED. FRAGMENT OF THE DEVICE REMAINING IN THE PATIENT WAS UNKNOWN. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WAS UNKNOWN. IT WAS UNKNOWN WHETHER ANY TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT OR NOT. PATIENT WAS ALIVE AND NO INJURY. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482187 ↗
• MalfunctionAug 26, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF LUMBAR DISCECTOMY USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE CROSS LINK WAS IMPLANTED, THE TAPERED PROTRUSION OF THE CROSS LINK BROKE AND FELL OFF, AND THE FIXATION OF THE CROSS LINK FAILED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME 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 Known Impact Or Consequence To Patient

  MAUDE report 10452818 ↗
• MalfunctionAug 26, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF LUMBAR DISCECTOMY USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE CROSS LINK WAS IMPLANTED, THE TAPERED PROTRUSION OF THE CROSS LINK BROKE AND FELL OFF, AND THE FIXATION OF THE CROSS LINK FAILED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME 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 Known Impact Or Consequence To Patient

  MAUDE report 10452807 ↗
• MalfunctionAug 24, 2020Break; Device Fell; Break; Device Fell

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SPINAL FRACTURE INVOLVED IN SPINAL REDUCTION AND INTERNAL FIXATION PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE, THE FIXATION CROSSLINK BROKE AND FELL OFF, THAT MADE UNABLE TO FIX. THERE IS NO FRAGMENT LEFT IN THE PATIENT. THERE IS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS THE RESULT OF EVENT. THERE IS NO ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10441251 ↗
• MalfunctionDec 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A REVISION SURGERY AT T9-T10. INTRA-OP, WHEN PLACING THE CROSSLINK, SET SCREW OF THE CROSSLINK STRIPPED; SO, THE SURGEON REPLACED THE ENTIRE CROSSLINK WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9435077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio