FDA Adverse Event
Injury
Summary report: N
CAVUX CERVICAL CAGE-X
MDR report key: 15396529
·
Received September 9, 2022
Report
- Report Number
- 3009394448-2022-00005
- Event Type
- Injury
- Date Received
- September 9, 2022
- Date of Event
- August 18, 2022
- 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 HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THERE WAS NO DEVICE MALFUNCTION, REVISION PROCEDURE WAS DUE TO MALPOSITION. THE INDEX PROCEDURE WAS A TWO-LEVEL CASE AT C4-C6 ON (B)(6), 2022. POST INDEX PROCEDURE, PATIENT WAS REFERRED DUE TO PAIN. REVISION PROCEDURE TO REMOVE CAGE ON THE LEFT SIDE AT C4-C5 TOOK PLACE ON (B)(6), 2022. THE CASE WAS COMPLETED SUCCESSFULLY AND PATIENT IS RECOVERING AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1708769 | CAVUX CERVICAL CAGE-X | CERVICAL CAGE | ODP | PROVIDENCE MEDICAL TECHNOLOGY, INC. | PD-31-203 | CX212201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Required Intervention |