MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-12-20 for EVOLVE STEM 496-S095 manufactured by Wright Medical Technology, Inc..
Report Number | 1043534-2000-00123 |
MDR Report Key | 310684 |
Report Source | 05,06 |
Date Received | 2000-12-20 |
Date of Event | 2000-11-15 |
Date Mfgr Received | 2000-11-28 |
Device Manufacturer Date | 2000-04-01 |
Date Added to Maude | 2001-01-05 |
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 | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | DEBBY DAURER |
Manufacturer Street | 5677 AIRLINE RD |
Manufacturer City | ARLINGTON TN 38002 |
Manufacturer Country | US |
Manufacturer Postal | 38002 |
Manufacturer Phone | 9018674601 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | EVOLVE STEM |
Generic Name | SMALL JOINT COMPONENT |
Product Code | KIG |
Date Received | 2000-12-20 |
Returned To Mfg | 2000-12-05 |
Model Number | NA |
Catalog Number | 496-S095 |
Lot Number | 040A099818 |
ID Number | NA |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
Implant Flag | Y |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 300546 |
Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
Manufacturer Address | 5677 AIRLINE RD ARLINGTON TN 38002 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2000-12-20 |