MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-11 for IDUO G2 M57230600210 manufactured by Conformis, Inc..
| Report Number | 3004153240-2019-00278 |
| MDR Report Key | 9306516 |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2012-05-31 |
| Date Added to Maude | 2019-11-11 |
| 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 | PAUL SMOLENSKI |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 7813459093 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IDUO G2 |
| Generic Name | BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM |
| Product Code | NPJ |
| Date Received | 2019-11-11 |
| Catalog Number | M57230600210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS, INC. |
| Manufacturer Address | 600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-11 |