MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2008-05-14 for INTERPHLEX UNK manufactured by Osteomed L.p..
[838365]
Quote in july 2006 "podiatry today" indicates that physician had two cases, where he had to remove a stabilization rod due to an inflammatory reaction. One of these cases was previously reported to company any filed as mdr in 2004. When doctor was contacted regarding second case, he indicated he was unable to find the file or provide further information. This was early in the practice with this product surgeon remains a current user today.
Patient Sequence No: 1, Text Type: D, B5
[8000191]
Device not returned. No additional information available. Doctor said he was unable to locate file. Previous other report filed in 2004 as mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2008-00007 |
| MDR Report Key | 1047162 |
| Report Source | 03 |
| Date Received | 2008-05-14 |
| Date of Report | 2008-05-14 |
| Date Mfgr Received | 2008-04-14 |
| Date Added to Maude | 2008-05-23 |
| 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 ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERPHLEX |
| Generic Name | FLEXIBLE STABILIZATION ROD |
| Product Code | LZJ |
| Date Received | 2008-05-14 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1016505 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-14 |