MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-10-22 for TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM STA-P4; STA-D7 manufactured by Tornier Inc..
[2724830]
It is reported that a stayfuse toe joint prosthesis device became disconnected about six weeks post implantation and required a replacement unit. Date of initial implant has not yet been provided. Radiographs requested have not yet been provided. Explanted device has been recovered for examination. The explanted failed device is a mated component pair: sta-p4, lot k10660, expiry march 2013; sta-d7, lot k10621, expiry february 2013. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610667-2009-00024 |
| MDR Report Key | 2627503 |
| Report Source | 08 |
| Date Received | 2009-10-22 |
| Date of Report | 2009-10-22 |
| Date of Event | 2009-09-24 |
| Date Mfgr Received | 2009-10-05 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RALPH BARISANO, VP |
| Manufacturer Street | 100 CUMMINGS CENTER SUITE 444C |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9782329997 |
| Manufacturer G1 | TORNIER INC. |
| Manufacturer Street | 3601 W. 76TH ST SUITE 200 |
| Manufacturer City | EDINA MN 55435 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55435 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM |
| Generic Name | SCREW, FIXATION, BONE |
| Product Code | NDF |
| Date Received | 2009-10-22 |
| Returned To Mfg | 2009-09-30 |
| Catalog Number | STA-P4; STA-D7 |
| Lot Number | K10660; K10621 |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-10-22 |