MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-25 for ARTELON CMC SPACER manufactured by Artimplant Ab, Or Small Bone Innovations Inc..
[18275228]
The reporter was diagnosed with osteoarthritis on her right thumb in (b)(6) 2010. She had surgery done on (b)(6) 2010, where she was implanted with the artelon cmc spacer. Since then she has suffered from pain, loss of range of motion, and discomfort. She is not satisfied with the result from the surgery, and now no doctor can help her. She tried contacting the surgeon who did the surgery with no good result. She met with another doctor who cannot help her. She is filing this complaint to add her name to the record that she has a problem with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029970 |
| MDR Report Key | 3084995 |
| Date Received | 2013-04-25 |
| Date of Report | 2013-04-25 |
| Date of Event | 2010-09-01 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| 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 | ARTELON CMC SPACER |
| Generic Name | SPACER |
| Product Code | KYI |
| Date Received | 2013-04-25 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTIMPLANT AB, OR SMALL BONE INNOVATIONS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-25 |