MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for CARTIVA SCI manufactured by Cartiva, Inc..
[146104482]
On (b)(6) 2018, i had a cartiva implant on my toe. The pain is progressively getting worse since i had the surgery. It's hard for me to walk or exercise. I have gained weight. I was told my surgery was a failure by my dr. I am refusing to have another surgery at this time, i can't afford to take time off from work or another surgery. The dr told me i would be considered a success because i'm not getting another surgery. This is misleading and very disappointing that the fda would back this product. It should be removed from the market. I have developed pain in my knee and hip being that i am trying to keep weight off my big toe when i walk. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086840 |
| MDR Report Key | 8636148 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-20 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARTIVA SCI |
| Generic Name | PROSTHESIS, METATARSUPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT |
| Product Code | PNW |
| Date Received | 2019-05-22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARTIVA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-22 |