PRESTIGE(TM) CERVICAL DISC SYSTEM
Report
- Report Number
- 1030489-2024-01067
- Event Type
- Malfunction
- Date Received
- September 2, 2024
- Date of Event
- July 25, 2024
- Report Date
- November 13, 2024
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- MJO
- PMA / PMN Number
- SEE H11
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B1: UPDATED ADVERSE EVENT/PRODUCT PROBLEM. 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.
G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE CATALOG # 6961460, PMA #P060018, UDI: (B)(4) WAS CLEARED IN THE UNITED STATES. H6 - NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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.
RADIOGRAPHIC IMAGE REVIEW RESULTS: LATERAL CERVICAL X-RAY LEVELS UNKNOWN CERVICAL DISC ARTHROPLASTY GRAFT IS EXTRUDED FORWARD UNDERNEATH 1 LEVEL ACDF. B5: EVENT DESCRIPTION UPDATED. 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 (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH CERVICAL DISC HAVING CERVICAL ARTHROPLASTY PROCEDURE. IT WAS REPORTED THAT DR HAS NOT HAD A GOOD RESULT IN THE POST-OPERATIVE PERIOD OF THE PRESTIGE DISC PROSTHESIS. THE PROCEDURE ON (B)(6) 2024 WAS MONITORED TO CONFIRM THAT THE SURGICAL TECHNIQUE INFORMED BY MEDTRONIC WAS FOLLOWED AND EVERYTHING WENT WELL IN ALL STAGES OF THE SURGERY. HOWEVER, THE PRESTIGE PROSTHESIS HAD MIGRATED POST-OP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
ADDITIONAL INFORMATION RECEIVED THAT DR IS CONSIDERING EXPLANTING THE PRESTIGE DISC PROSTHESIS TO AVOID COMPLICATIONS FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 916840 | PRESTIGE(TM) CERVICAL DISC SYSTEM | PROSTHESIS, INTERVERTEBRAL DISC | MJO | WARSAW ORTHOPEDICS | 6971250 | 0926270W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |