MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for ORTHOSORB manufactured by Johnson And Johnson Orthopedics.
[8682]
Osteolysis of the first metatarsal head secondary to the surgical implantation of a pin for skeletal fixation with bunionectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000204 |
| MDR Report Key | 11519 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-04-16 |
| Date of Event | 1992-12-07 |
| Date Added to Maude | 1994-02-17 |
| 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 | ORTHOSORB |
| Product Code | MBJ |
| Date Received | 1994-02-07 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11519 |
| Manufacturer | JOHNSON AND JOHNSON ORTHOPEDICS |
| Manufacturer Address | RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-07 |