MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-04 for ARTIMPLANT manufactured by Artelon.
[4346508]
Patient stepped on a loose fitting water drain cover and incurred an ankle fracture. A cast was applied on the ankle for 7 days. When cast was taken off, injury was unhealed. The biodegradeable artimplant was then implanted in a bid to reinforce the tendon at her ankle. Immediately after the surgery, the implant was not closing up, and so created an open wound at her ankle. She's been in total discomfort and unable to ambulate since then. She has been back to the hospital 16 times and has had several surgeries with dr (b)(6) of (b)(6). The device did not disintegrate as advertised. Until yesterday, patient was in pain and with an open wound. Patient eventually changed doctors and the device was explanted. Patient questions the fda approval process and is now demanding justice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034832 |
| MDR Report Key | 3667640 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-03-04 |
| Date of Event | 2012-01-04 |
| Date Added to Maude | 2014-03-10 |
| 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 |
| 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 | ARTIMPLANT |
| Generic Name | TISSUE REINFORCEMENT PATCH |
| Product Code | KYI |
| Date Received | 2014-03-04 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTELON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-03-04 |