CORNERSTONE-SR® TI-COATED CAGE SYSTEM
Report
- Report Number
- 3011795235-2025-00017
- Event Type
- Malfunction
- Date Received
- October 6, 2025
- Report Date
- April 14, 2026
- Manufacturer
- MSD DEGGENDORF MFG
- Product Code
- ODP
- PMA / PMN Number
- SEE H11
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G4: THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG#: 5030564 AND 510K#: K133653 IS APPROVED FOR SALE IN US. 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.
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.
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.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT IMPLANTED WITH CAGE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE BROKEN AND PATIENT SYMPTOMS WERE UNKNOWN. REVISION SURGERY WAS PERFORMED TO EXPLANT IMPLANTS ON (B)(6) 2025. EVENT OCCURRED POST-OP AND LEVEL IMPLANTED ¿ CERVICAL VERTEBRAE 5/6 AND 6/7. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
ADDITIONAL INFORMATION RECEIVED THAT THESE IMPLANTS WERE MASSIVELY CORRODED AND DISINTEGRATED. THIS RESULTED IN SEVERE METALLOSIS, SYSTEMIC SWELLING, AND LIFE-THREATENING INFLAMMATION LEVELS.
ADDITIONAL INFORMATION RECEIVED THAT PATIENT HAD SIGNIFICANT NECK SWELLING, VENOUS PROBLEMS, FACIAL AND BODY SWELLING, AND CATASTROPHIC BLOOD TEST RESULTS. AFTER IMPLANTS WERE EXPLANTED, PATIENT'S CONDITION WAS GETTING BETTER, BUT THE SWELLING RETURNED AND WORSENED. PATIENT ALSO HAD PAINS LIKE BROKEN LIMBS (IN EPISODES) IN FINGERS, ANKLES, KNEES, AND SPREADING THROUGHOUT THE BODY. ON AN MRI, METAL FRAGMENTS WERE VISIBLE AT THE SURGICAL SITE. PATIENT WAS ALLERGIC TO NICKEL, AND BLOOD PRESSURE WAS HIGH AND HAD HEART AND LUNG PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183054 | CORNERSTONE-SR® TI-COATED CAGE SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, | ODP | MSD DEGGENDORF MFG | 6221404 | 09RE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |