MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-31 for CLASSIC GREAT TOE IMPLANT SIZE 50 CGT-050 manufactured by Tornier Inc.
[3173705]
Device implanted on (b)(6) 2011. Explanted on (b)(6) 2012. The implant was broken , had substantial pitting and had changed to an extreme yellow color. Device was replaced with another of the same type of implant.
Patient Sequence No: 1, Text Type: D, B5
[10579031]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2013-00001 |
| MDR Report Key | 2979984 |
| Report Source | 05 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-23 |
| Date of Event | 2012-11-26 |
| Date Mfgr Received | 2013-01-23 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2013-02-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9524267643 |
| Manufacturer G1 | TORNIER INC. |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC GREAT TOE IMPLANT SIZE 50 |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2013-01-31 |
| Catalog Number | CGT-050 |
| Lot Number | 120330709E |
| Device Expiration Date | 2014-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-31 |