MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-01-08 for SUBTALAR M.B.A. * manufactured by Kinetikos Medical, Inc..
[15376391]
On dec 2003 k. M. I. Was informed of the explant of a subtalar m. B. A. In 2003 from a pt to address pain. The original implant date was in 2002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028840-2003-00034 |
| MDR Report Key | 505711 |
| Report Source | 05,06 |
| Date Received | 2004-01-08 |
| Date of Event | 2003-12-22 |
| Date Added to Maude | 2004-01-13 |
| 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 Street | 6005 HIDDEN VALLEY RD SUITE #180 |
| Manufacturer City | CARLSBAD CA 92009 |
| Manufacturer Country | US |
| Manufacturer Postal | 92009 |
| Manufacturer Phone | *4481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBTALAR M.B.A. |
| Generic Name | ORTHOPAEDIC FOOT IMPLANT |
| Product Code | ISH |
| Date Received | 2004-01-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 494581 |
| Manufacturer | KINETIKOS MEDICAL, INC. |
| Manufacturer Address | 6005 HIDDEN VALLEY ROAD SUITE 180 CARLSBAD CA 92009 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-01-08 |