CD HORIZON® SPINAL SYSTEM
Received Jul 1, 2026 · Event occurred Jun 3, 2026
Report 3003120897-2026-01140 · MDR key 25680998
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Medtronic Sofamor Danek Usa, Inc.Model number
7578302Catalog number
7578302
Lot number
EM24K003
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING AN EXTENDER. IT WAS REPORTED THAT SCREW CANNOT BE SECURED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.