MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-29 for ORTHOSORB ABSORBABLE PIN GP7098 84-1070 manufactured by Johnson & Johnson Orthopaedics Group.
[18619]
Modified mcbride procedure on right foot, bunionectomy/osteotomy. Cellulitis developed post-op which did not respond to medical treatment. Return to or 3/13/96 for bone biopsy which showed osteomyelitis of the dorsum of the right foot. Pt continues to have increasing osteomyelitis of the right foot and ankle. Surgeon believes implant was not sterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32886 |
| MDR Report Key | 32886 |
| Date Received | 1996-04-29 |
| Date of Report | 1996-04-29 |
| Date of Event | 1996-01-26 |
| Date Facility Aware | 1996-04-03 |
| Report Date | 1996-04-29 |
| Date Reported to Mfgr | 1996-04-29 |
| Date Added to Maude | 1996-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB ABSORBABLE PIN |
| Generic Name | ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1996-04-29 |
| Model Number | GP7098 |
| Catalog Number | 84-1070 |
| Device Expiration Date | 2000-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 34186 |
| Manufacturer | JOHNSON & JOHNSON ORTHOPAEDICS GROUP |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 027671086 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-29 |