FDA Adverse Event
Injury
Summary report: N
CAVUX CERVICAL CAGE-X
MDR report key: 19907239
·
Received August 5, 2024
Report
- Report Number
- 3009394448-2024-00002
- Event Type
- Injury
- Date Received
- August 5, 2024
- Date of Event
- June 18, 2024
- Report Date
- August 5, 2024
- Manufacturer
- PROVIDENCE MEDICAL TECHNOLOGY, INC
- Product Code
- ODP
- PMA / PMN Number
- K122801
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THERE WAS NO DEVICE MALFUNCTION, REVISION PROCEDURE WAS DUE TO POST-OP PAIN, IT WAS NOTED THAT THE PATIENT HAS HAD MULTIPLE NECK SURGERIES. THE INDEX PROCEDURE WAS A TWO-LEVEL CASE AT (B)(4) ON (B)(6) 2024. ON (B)(6) 2024 PMT WAS NOTIFIED THAT POST INDEX PROCEDURE, PATIENT EXPERIENCE PAIN AND UNDERWENT A REVISION PROCEDURE TO REMOVE CAGES ON BOTH SIDES. THE CASE WAS COMPLETED SUCCESSFULLY. AT THE TIME OF THIS REPORT, THERE WAS NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1780227 | CAVUX CERVICAL CAGE-X | Intervertebral fusion device with bone graft, cervical | ODP | PROVIDENCE MEDICAL TECHNOLOGY, INC | PD-31-203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Unknown | Required Intervention |