MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-06 for RTS FLEXIBLE 1AT MPJ IMPLANT M30 SE010 manufactured by In2bones Usa.
| Report Number | 3011580264-2019-00015 |
| MDR Report Key | 8969779 |
| Date Received | 2019-09-06 |
| Date of Report | 2019-09-06 |
| Date of Event | 2019-08-09 |
| Date Mfgr Received | 2019-08-09 |
| Date Added to Maude | 2019-09-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CRISTI MANN |
| Manufacturer Street | 6000 POPLAR AVE SUITE 115 |
| Manufacturer City | MEMPHIS TN 38119 |
| Manufacturer Country | US |
| Manufacturer Postal | 38119 |
| Manufacturer Phone | 9012607931 |
| Manufacturer G1 | IN2BONES USA |
| Manufacturer Street | 6000 POPLAR AVE SUITE 115 |
| Manufacturer City | MEMPHIS TN 38119 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38119 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RTS FLEXIBLE 1AT MPJ IMPLANT |
| Generic Name | RTS REFERENCE TOE |
| Product Code | KWH |
| Date Received | 2019-09-06 |
| Returned To Mfg | 2019-08-14 |
| Model Number | M30 SE010 |
| Lot Number | 9G0HM0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IN2BONES USA |
| Manufacturer Address | 6000 POPLAR AVE SUITE 115 MEMPHIS TN 38119 US 38119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-06 |