MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-25 for SMART-TOE * ST0-16 manufactured by Memometal.
[15190247]
Portion of implant removed from foot.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1489927 |
MDR Report Key | 1489927 |
Date Received | 2009-09-25 |
Date of Report | 2009-09-25 |
Date of Event | 2009-09-18 |
Report Date | 2009-09-25 |
Date Reported to FDA | 2009-09-25 |
Date Added to Maude | 2009-10-05 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SMART-TOE |
Generic Name | IMPLANT, ORTHOPEDIC, TOE |
Product Code | LZJ |
Date Received | 2009-09-25 |
Model Number | * |
Catalog Number | ST0-16 |
Lot Number | 07338-10-0698A-M51 |
ID Number | * |
Device Availability | N |
Device Age | 1 DY |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEMOMETAL |
Manufacturer Address | 6000 POPLAR AVENUE, SUITE 110 MEMPHIS TN 38119 US 38119 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2009-09-25 |