MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-02-25 for ORTHOSORB ABSORBABLE PIN 84-1050 manufactured by Johnson & Johnson Professional, Inc..
[7828242]
H6-podiatric consultant examined patient notes, operative and follow-up notes, pathology report, and x-rays. Review of materials indicate foreign body reaction likely to have taken place. Incidence of complaints to be monitored for further occurrence.
Patient Sequence No: 1, Text Type: N, H10
[21717227]
Reverse bunionectomy procedure was performed on patient's right foot. At approximately 3 months post-op, patient experienced pain, edema, and x-rays found resorption of fifth metatarsal head. Possible adverse reaction to absorbable pin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1997-00047 |
| MDR Report Key | 71052 |
| Report Source | 05 |
| Date Received | 1997-02-25 |
| Date of Report | 1997-02-25 |
| Date Mfgr Received | 1997-02-20 |
| Date Added to Maude | 1997-02-26 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB ABSORBABLE PIN |
| Generic Name | ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1997-02-25 |
| 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 | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 70952 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 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 | 1997-02-25 |