MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-10-09 for REFLEXION TOE SYSTEM 370-0423 manufactured by Osteomed L.p..
[1182505]
Pt implanted in 2008. Approx 4 weeks postop, pt showed signs of warmth or redness around implant site. No complaints made to company at that time. On 9/9/2009, the rep was informed that the pt was to be re-operated. The pt had been put on iv antibiotics in intervening period, although, all blood cultures and bone biopsies were negative for infection. Doctor indicated he believes pt had an allergic reaction to implant because she "had sensitivity to certain types of earrings" going back several years. The ifu cautions against use of the product in pts with known metal sensitivities. No similar complaints have been received in the last year.
Patient Sequence No: 1, Text Type: D, B5
[8421348]
Product is not expected to be returned to company. This info is based on verbal interview of surgeon.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2009-00009 |
| MDR Report Key | 1508378 |
| Report Source | 05,07 |
| Date Received | 2009-10-09 |
| Date of Report | 2009-10-09 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-09-09 |
| Date Added to Maude | 2009-10-20 |
| 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 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 SYSTEM |
| Generic Name | 1ST MPJ JOINT |
| Product Code | LZJ |
| Date Received | 2009-10-09 |
| Model Number | 370-0423 |
| Catalog Number | 370-0423 |
| Lot Number | 1021716 |
| Device Expiration Date | 2012-06-30 |
| 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. Required No Informationntervention | 2009-10-09 |