MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-28 for MIDWEST PUSH BUTTON LATCH TYPE HEAD 720485 manufactured by Sirona Dental Systems Gmbh.
[184709106]
When received from customer, immediately noticed the push button on head assembly was pressed in too far. When burr was inserted into head assembly it could be pulled back out manually. This was because of the push button having no spring back to it. The head assembly had to be separated using two pairs of pliers. Very heavy debris on threads and inside of head assembly. This may have caused the push button to fail and not able to lock in burr.
Patient Sequence No: 1, Text Type: N, H10
[184709107]
It was reported that a midwest push button latch type head contra angle won't hold burs; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00159 |
| MDR Report Key | 9637609 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2019-12-19 |
| 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 |
| 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, 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 PUSH BUTTON LATCH TYPE HEAD |
| Generic Name | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL |
| Product Code | EGS |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-09 |
| Model Number | NA |
| Catalog Number | 720485 |
| 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 | 2020-01-28 |