MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2008-10-16 for SWANSON TITANIUM GREAT TOE IMPLANT manufactured by Wright Medical Technology, Inc..
[971569]
In the foot & ankle international, vol. 27, no. 11, november 2006 issue, dr. Kurt frederick konkel and dr. Andrea gayle menger published an article titled "mid-term results of titanium hemi-great toe implants", where 12 (16 toes) patients had insertion of a titanium hemi-great toe implant. Allegedly two components shifted, one component had site ulcer, and one component had trauma related break. One shifted component was treated with z-plasty tendon, skin & capsule. The other shifted component was treated with weil osteotomy. The component with a site ulcer had debridement and secondary closure performed. And the broken component was treated with debridement and cheilectomy mtp joint.
Patient Sequence No: 1, Text Type: D, B5
[8236791]
Investigation is not complete. Event device code is addressed in package insert. Trends will be evaluated. This report will be updated wen the investigation is complete. This literature source did not provide information on the user facility, implantation dates, nor dates of complications. A medwatch 3500a has not been received. (see scanned pages).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2008-00308 |
| MDR Report Key | 1199965 |
| Report Source | 03,07 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-10-14 |
| Date Mfgr Received | 2008-10-14 |
| Date Added to Maude | 2008-10-22 |
| 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 | 0 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON TITANIUM GREAT TOE IMPLANT |
| Generic Name | NONE |
| Product Code | LZJ |
| Date Received | 2008-10-16 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1247478 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-10-16 |