MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-10 for LIGHT WIRE FORMING PLIER WITH CUTTER 032-GC * manufactured by Orthopli Corp.
[903656]
During the procedure the pliers used to bend dental band broke at the tip on one side, while in the patient's mouth. The surgeon examined the oral cavity to assure no metal was seen. Oral cavity also flushed out with water. No metal instruments tip found. Patient discharged home without issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1081154 |
| MDR Report Key | 1081154 |
| Date Received | 2008-07-10 |
| Date of Report | 2008-07-10 |
| Date of Event | 2008-07-01 |
| Report Date | 2008-07-10 |
| Date Reported to FDA | 2008-07-10 |
| Date Added to Maude | 2008-07-28 |
| 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 |
| 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 | LIGHT WIRE FORMING PLIER WITH CUTTER |
| Generic Name | PLIERS, DENTAL |
| Product Code | JEX |
| Date Received | 2008-07-10 |
| Model Number | 032-GC |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1047623 |
| Manufacturer | ORTHOPLI CORP |
| Manufacturer Address | 10061 SANDMEYER LANE PHILADELPHIA PA 19116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-10 |