MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for CARTIVA manufactured by Cartiva.
[146621372]
Revision of approved implant that was significantly damaged and had decreased in size since initial implantation. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086960 |
| MDR Report Key | 8650723 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-23 |
| Date of Event | 2018-12-27 |
| Date Added to Maude | 2019-05-29 |
| 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 |
| 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 |
| Generic Name | PROSTHESIS, TOE, HEMI, PHALANGEAL |
| Product Code | KWD |
| Date Received | 2019-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARTIVA |
| Manufacturer Address | ALPHARETTA GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-28 |