MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 1997-04-16 for ORTHOSORB ABSORBABLE PIN 84-1050 manufactured by Johnson & Johnson Professionals, Inc..
[50617]
An article in the journal of the american podiatric medical association reported a foreign body reaction involving a 40 year old female pt who had undergone an osteotomy of the fourth metatarsal head. The pt had experienced persistent pain and x-rays revealed an area of lucency at the osteotomy site. The pt was diagnosed with a delayed union caused by foreign-body reaction to two absorbable bone pins used in the procedure. The article reported a second surgery in which the osteotomy was fixated with a kirschner wire. The pt was placed in a nonweight bearing below the knee cast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1997-00079 |
| MDR Report Key | 83779 |
| Report Source | 03 |
| Date Received | 1997-04-16 |
| Date of Report | 1997-04-16 |
| Date Mfgr Received | 1997-03-24 |
| Date Added to Maude | 1997-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB ABSORBABLE PIN |
| Generic Name | ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1997-04-16 |
| Model Number | NA |
| Catalog Number | 84-1050 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 83083 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 027670350 US |
| Baseline Brand Name | ORTHOSORB ABSORBABLE PIN |
| Baseline Generic Name | ABSORBABLE PIN |
| Baseline Model No | NA |
| Baseline Catalog No | 84-1050 |
| Baseline ID | * |
| Baseline Device Family | ORTHOSORB ABSORBABLE PIN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901456 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-16 |