MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for CARTIVA SCI manufactured by Cartiva, Inc..
[122168122]
Received a cartiva implant in the metatarsophalangeal joint for treatment of hallux rigidus. Pain in creased after surgery. After 4 weeks the device recessed back in to the metatarsal bone and flattened so that there was no longer a space in the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080169 |
| MDR Report Key | 7914481 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-25 |
| Date of Event | 2017-10-20 |
| Date Added to Maude | 2018-09-27 |
| 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 METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT |
| Product Code | LZJ |
| Date Received | 2018-09-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other; 2. Deathisabilit | 2018-09-26 |