MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for FUTURA FGT SIZE 20 IMPLANT FGT-20 manufactured by Tornier Inc.
| Report Number | 3004983210-2019-00043 |
| MDR Report Key | 8859875 |
| Date Received | 2019-08-05 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-07-24 |
| Date Added to Maude | 2019-08-05 |
| 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 | MS. MARY MCNABB |
| Manufacturer Street | 4375 E PARK 30 DRIVE |
| Manufacturer City | COLUMBIA CITY IN 46725 |
| Manufacturer Country | US |
| Manufacturer Postal | 46725 |
| Manufacturer Phone | 5743713153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FUTURA FGT SIZE 20 IMPLANT |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2019-08-05 |
| Catalog Number | FGT-20 |
| Lot Number | CT0115126 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC |
| Manufacturer Address | 10801 NESBITT AVENUE S BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-05 |