MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for CARTIVA SCI CAR-10-US manufactured by Cartiva, Inc.
[188208039]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[188208040]
It was reported that the patient complained of significant pain and drainage. Upon review after removal the implant looked to be damaged or blemished on the articulating surface.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2020-00053 |
| MDR Report Key | 9853339 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | CARTIVA, INC |
| Manufacturer Street | 6120 WINDWARD PARKWAY SUITE 220 |
| Manufacturer City | ALPHARETTA GA 30005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARTIVA SCI |
| Generic Name | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT |
| Product Code | PNW |
| Date Received | 2020-03-19 |
| Model Number | CAR-10-US |
| Lot Number | F011719001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARTIVA, INC |
| Manufacturer Address | 6120 WINDWARD PARKWAY SUITE 220 ALPHARETTA GA 30005 US 30005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |