MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-11-13 for BIOACTION TOE SYSTEM 350X manufactured by Osteomed L.p..
[1517268]
The pt complained of "inflation" and irritation from initial implantation. Initial x-rays showed proper implant positioning but, over time, a slight "halo" developed around the root of the implant. This indicated poor bone-to-implant contact. Over the next year, the implant loosened further resulting in complete loosening and removal on (b) (6) 2009. No bone cement was used. Instructions for use state that device is only to be used with bone cement. Implant was disposed off after explant. Doctor decided to leave the joint unfused.
Patient Sequence No: 1, Text Type: D, B5
[8337423]
Doctor disposed off device after explant and the device is not available for evaluation. Doctor did not use bone cement when placing the device. Instructions for use clearly state that it is intended for use with bone cement only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2009-00010 |
| MDR Report Key | 1555852 |
| Report Source | 05,07 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-07-07 |
| Date Mfgr Received | 2009-10-27 |
| Date Added to Maude | 2010-02-04 |
| 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 | BIOACTION TOE SYSTEM |
| Generic Name | 1ST MPJ JOINT |
| Product Code | LZJ |
| Date Received | 2009-11-13 |
| Model Number | 350X |
| Catalog Number | 350X |
| Lot Number | UNK |
| 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 | 2009-11-13 |