MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-13 for FIT CHECKER manufactured by Gc America.
[13713]
A silicone material used to detect unfitness of a dental prosthesis became imbedded within the periosteum. A mucoperiosteal flap was raised from tooth #13 to 5. An alveolectomy was performed and 7 teeth were extracted. The device was placed in the immediate maxillary denture to evaluate for impinging regions. Some of the silicone extruded into the extraction sockets and then underneath the flap and into the periosteum. An attempt to remove all the visible silicone material was immediately performed. The flap was sutured with bss and immediately the maxillary complete denture was inserted. The pt did not achieve post-surgical comfort until a subsequent extensive debridement and currettage of the anterior maxilla was performed. The pathological diagnosis from the tissue report was portions of benign bone and soft tissue with focal reaction. There was no foreign body in the specimen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006227 |
| MDR Report Key | 22435 |
| Date Received | 1995-06-13 |
| Date of Report | 1995-05-29 |
| Date of Event | 1995-02-14 |
| Date Added to Maude | 1995-06-14 |
| 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 | DENTIST |
| 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 | FIT CHECKER |
| Generic Name | FIT CHECKER |
| Product Code | KGM |
| Date Received | 1995-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22600 |
| Manufacturer | GC AMERICA |
| Manufacturer Address | CHICAGO IL 60658 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-06-13 |