MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for MIDWEST TRADITION PRO HANDPIECE 790345 manufactured by Sirona Dental Systems Gmbh.
[184707228]
Additional serial numbers included in this report: (b)(4). 7 of 7 devices were returned for evaluation. Evaluation of 3 devices found chuck wear and lack of maintenance. The devices were cleaned of debris and the turbines were replaced. The devices were repaired and returned to the customers. Evaluation of 4 devices found normal chuck wear and the turbines needed to be replaced. The devices were repaired and returned to the customers.
Patient Sequence No: 1, Text Type: N, H10
[184707229]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00177 |
| MDR Report Key | 9639590 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Street | FABRIKSTRASSE 31 |
| Manufacturer City | BENSHEIM, D-64625 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-64625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDWEST TRADITION PRO HANDPIECE |
| Generic Name | HANDPIECE, AIR-POWERED, DENTAL |
| Product Code | EFB |
| Date Received | 2020-01-28 |
| Model Number | NA |
| Catalog Number | 790345 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |