MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-20 for MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT 875205 manufactured by Sirona Dental Systems Gmbh.
[139455432]
Handpiece didn't get hot. Handpiece failed specs due to gear on turbine broken in half, causing the handpiece to run loud/rough during testing. Also found rust built up in turbine. Dry bearings.
Patient Sequence No: 1, Text Type: N, H10
[139455433]
It was reported that a midwest e plus 1:5 ca overheated during use; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00030 |
| MDR Report Key | 8438897 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-13 |
| Date Added to Maude | 2019-03-20 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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, HESSEN 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 E PLUS 1:5 HIGHSPEED ATTACHMENT |
| Generic Name | HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
| Product Code | EFA |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-02-26 |
| Model Number | NA |
| Catalog Number | 875205 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-20 |