MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-18 for ORTHOSORB ABSORBABLE PIN UNK manufactured by Johnson And Johnson Professional, Inc..
[18475451]
Device was used to stabilize a bone. Pt was suffering from continuous swelling. X-rays were taken and it revealed extreme resorption of metatarsal head secondary to the use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010284 |
| MDR Report Key | 50185 |
| Date Received | 1996-11-18 |
| Date of Report | 1996-11-18 |
| Date of Event | 1996-09-11 |
| Date Added to Maude | 1996-11-21 |
| 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 ABSORBABLE PIN |
| Generic Name | BIODEGRADABLE, HARD TISSUE, BONE FIXATOR |
| Product Code | MBJ |
| Date Received | 1996-11-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 50900 |
| Manufacturer | JOHNSON AND JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 027670350 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-18 |