FDA Adverse Event
Injury
Summary report: N
CAVUX CERVICAL CAGE-T
MDR report key: 14319157
·
Received May 7, 2022
Report
- Report Number
- 3009394448-2022-00001
- Event Type
- Injury
- Date Received
- May 7, 2022
- Date of Event
- April 11, 2022
- Report Date
- May 6, 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
THIS EVENT DID NOT RESULT IN A DEATH OF LIFE-THREATENING INJURY. PATIENT PREVIOUSLY HAD MOBI-C TDR SURGERY AND WAS EXPERIENCING PAIN. SURGEON PLACED CAVUX CERVICAL CAGE-T IN 2 LEVEL BILATERAL PLACEMENT. ON A FOLLOWUP VISIT, IT WAS NOTED THAT THE CAGE-T WAS EXPELLED POSTERIORLY INTO SOFT TISSUE. SUCCESSFUL REVISION PROCEDURE WAS COMPLETED AT ONE LEVEL TO REMOVE CAGE-T AND REPLACED WITH CAGE-B 4MM. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 950309 | CAVUX CERVICAL CAGE-T | CERVICAL CAGE | ODP | PROVIDENCE MEDICAL TECHNOLOGY, INC. | PD-31-100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Unknown | Required Intervention |