MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-07 for BIOFIX LENGTH 20MM X 1.5MM DIA 121520 manufactured by Bionix Implants, Inc..
[20196956]
Pain and swelling to third toe distal inter-phalangeal joint right foot for 6 months duration. X-rays show silhouette of device through the bone. The pt stated pain and redness with swelling of toes in shoes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014384 |
| MDR Report Key | 182233 |
| Date Received | 1998-08-07 |
| Date of Report | 1998-07-31 |
| Date of Event | 1998-07-31 |
| Date Added to Maude | 1998-08-17 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFIX |
| Generic Name | 1.5MM X 20MM ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1998-08-07 |
| Model Number | LENGTH 20MM X 1.5MM DIA |
| Catalog Number | 121520 |
| Lot Number | 315 |
| ID Number | FIN-33721 TAMPERE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 177182 |
| Manufacturer | BIONIX IMPLANTS, INC. |
| Manufacturer Address | HERMIANKATU 6-8 L TAMPERE FI FIN-33720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-08-07 |