MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-26 for MAXIMA ELITE 1:5 6361849 manufactured by Sirona Dental Systems Gmbh.
[143259510]
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The customer returned three handpieces because they were unsure which handpiece was involved in the event. The investigation has shown, that there was no manufacturing or material failure at all 3 instruments. The heating up could not be reproduced during the investigation. Therefore a heating up can only be reasoned due to an unintended use of the device, e. G. While pressing the push-button during the operation. This causes a contact between the rotor and the push button cover and finally results in destruction of the push button cover etc. And overheating.
Patient Sequence No: 1, Text Type: N, H10
[143259511]
It was reported that a maxima elite 1:5 ca overheated and burned a patient. The patient was prescribed pain medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2019-00057 |
| MDR Report Key | 8555620 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-20 |
| Date of Event | 2019-02-14 |
| Date Added to Maude | 2019-04-26 |
| 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 | MAXIMA ELITE 1:5 |
| Generic Name | HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
| Product Code | EFA |
| Date Received | 2019-04-26 |
| Catalog Number | 6361849 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2019-04-26 |