MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-19 for REFLEXION TOE REFLEXION 370-0425 370-0425 manufactured by Osteomed L.p..
[15409965]
Patient received reflexion toe implant on (b) (6) 2009. After surgery patient had swelling with redness. In (b) (6), the patient had an elevated wbc (11,000) which then declined. In (b) (6) patient was admitted for a possible infection with wbc back at 11,000, severe redness and swelling. No fractures were present on the x-ray and none of the x-rays were consistent with osteomyelitis. Doctor placed the patient on an iv antibiotic. On (b) (6), 2010 the implant was removed. Doctor stated that he had questions about patient's postoperative compliance/infection control. Device history records showed no anomalies and sterile processing of implants met requirements.
Patient Sequence No: 1, Text Type: D, B5
[15657030]
Device not returned to company and is not expected to be returned for evaluation. During phone interview doctor indicated possible questions patient's compliance. Apparently went home and soaked the foot in a plastic grocery bag in ice during early post op period. Came to first post op visit with foot wrapped in a plastic bag. Patient indicated that he did a lot of walking in early post op. Ifu cautions that device is contraindicated in patients who may ignore the limitations of artificial joint replacement. Also, territory manager reported that during the initial implant procedure, instruments were dropped a couple of times and were "flashed" to complete the case. Ifu does not provide flash sterilization instructions and warns against sterilizing above 275 degrees f because it may damage some of the polymers in the instruments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2010-00004 |
| MDR Report Key | 1640215 |
| Report Source | 05 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-03-19 |
| Date Mfgr Received | 2010-02-19 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-03-30 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEXION TOE |
| Generic Name | GREAT TOE IMPLANT |
| Product Code | LZJ |
| Date Received | 2010-03-19 |
| Model Number | REFLEXION 370-0425 |
| Catalog Number | 370-0425 |
| Lot Number | 1027462 |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-19 |