MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-26 for INION AMERICA manufactured by Finnish Company ( Inion).
[1043901]
We did a series of cervical surgery cases 2 years ago with a resorbable plate and screws called "inion". We are now seeing a third case of what appears to be long term and unusual reactions to this resorbable product. (three pts so far). We did a small series of cases using resorbable plates and screws about 2 years ago. About 8 months after this, we saw a pt back who appeared to have some resorbtion of bone related to the plate screws. We reported this to the manufacturer and kept a watchful eye on this. We tracked this online and with the manufacturer and found no similar cases. This pt did not require re-operation, but is only now starting to fuse more solidly. Date of use: 2005 - 2006. Note: all related scans, reports and md notes are in the respective pt charts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009749 |
| MDR Report Key | 1296304 |
| Date Received | 2009-01-26 |
| Date of Report | 2009-01-21 |
| Date Added to Maude | 2009-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INION AMERICA |
| Generic Name | CERVICAL PLATE AND SCREWS |
| Product Code | OJB |
| Date Received | 2009-01-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FINNISH COMPANY ( INION) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-01-26 |