MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-09 for REFLEXION TOE 370-0XXX manufactured by Osteomed.
[595250]
Pt rec'd implant in 2005. Presented in june to a different surgeon. At that time surgeon believed phalangeal component had recessed into phalanx, due to possible original surgeon placement error, or pt trauma. Surgeon #2 took no action at that time. In 2006 pt re-presented and implant removed. At time of surgery the dorsal area of the metatarsal and phalanx appeared to have eroded and toe was sticking straight up.
Patient Sequence No: 1, Text Type: D, B5
[7942689]
Pt placed on bone stimulator post-explant. No anomalies noted on visual exam of prosthesis at 10x magnification. Previous clinical history indicates possible trauma or misplacement of implant. Use instructions caution about excessive stresses on implant. Implant not kept by osteomed - surgeon asked to have it returned. No further eval possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2007-00002 |
| MDR Report Key | 817637 |
| Report Source | 05 |
| Date Received | 2007-02-09 |
| Date of Report | 2007-02-09 |
| Date of Event | 2006-12-20 |
| Date Mfgr Received | 2007-01-09 |
| Date Added to Maude | 2007-02-16 |
| 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 | 3885 ARAPAHO RD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEXION TOE |
| Generic Name | METATARSAL IMPLANT |
| Product Code | LZJ |
| Date Received | 2007-02-09 |
| Returned To Mfg | 2007-01-10 |
| Model Number | 370-0XXX |
| Catalog Number | 370-0XXX |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 805123 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | * ADDISON TX * US |
| Baseline Brand Name | REFLEXION TOE |
| Baseline Generic Name | METATARSAL IMPLANT |
| Baseline Model No | 370-0XXX |
| Baseline Catalog No | 370-0XXX |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-09 |