FDA Adverse Event
Malfunction
Summary report: N
CARTIVA SCI
MDR report key: 7994696
·
Received October 23, 2018
Report
- Report Number
- 3009351194-2018-00008
- Event Type
- Malfunction
- Date Received
- October 23, 2018
- Date of Event
- September 24, 2018
- Report Date
- October 23, 2018
- Manufacturer
- CARTIVA, INC.
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION PROVIDED BY THE INVOLVED SURGEON ON (B)(6) 2018, A CARTIVA IMPLANT APPEARED "FRACTURE/SHEARED" WHEN RANGE MOTION MOVEMENTS WERE PERFORMED ON A PATIENT AFTER IMPLANTATION. THE DEVICE WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER CARTIVA DEVICE. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838423 | CARTIVA SCI | CARTIVA SCI | PNW | CARTIVA, INC. | CAR-10-US | F030118001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |