MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-27 for ELEVATOR HEIDBRINK DE 13/14 * 101-6054 manufactured by Nopa Instruments.
[449226]
The elevator tip broke off in the pt's bone during a tooth extraction. The dentist inquired about the pt being able to have an mri. The dr was advised against an mri since we believe surgical grade stainless steel may be magnetic. The broken tip is lodged in the pt's bone and wasnot removed by the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2006-16107 |
| MDR Report Key | 692877 |
| Date Received | 2006-03-27 |
| Date of Report | 2006-02-28 |
| Date of Event | 2006-02-28 |
| Date Facility Aware | 2006-02-28 |
| Report Date | 2006-03-24 |
| Date Reported to FDA | 2006-03-24 |
| Date Reported to Mfgr | 2006-03-24 |
| Date Added to Maude | 2006-03-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| 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 | ELEVATOR HEIDBRINK DE 13/14 |
| Generic Name | DENTAL ROOT TIP ELEVATOR |
| Product Code | EKO |
| Date Received | 2006-03-27 |
| Model Number | * |
| Catalog Number | 101-6054 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 682029 |
| Manufacturer | NOPA INSTRUMENTS |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-27 |