MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-25 for PROOSTEON IMPLANT 500 * 9030 manufactured by Interpore Int..
[60419]
Put in pelvis to repair broken graft site bone. Screws/wire were used very low in pelvic stress area. Rptr had infection 3 days prior in the same area where break was, used new soft tissue, no plate used. Proosteon ate insides, was popping out of skin, caused infection etc. Rptr now has osteoporosis of 70 to 80 year old woman from this and need help from company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001927 |
| MDR Report Key | 100739 |
| Date Received | 1997-06-25 |
| Date of Report | 1997-06-12 |
| Date Added to Maude | 1997-06-27 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | PROOSTEON IMPLANT 500 |
| Generic Name | ENDOSSEOUS BONE FILLER |
| Product Code | MBS |
| Date Received | 1997-06-25 |
| Model Number | * |
| Catalog Number | 9030 |
| Lot Number | 314504 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 99250 |
| Manufacturer | INTERPORE INT. |
| Manufacturer Address | 181 TECHNOLOGY DR IRVINE CA 92718 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 1997-06-25 |