MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for ROOT FILLER L V040393021030 manufactured by Dentsply Vdw Gmbh.
[103553082]
There has been a previous report with the same product 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 device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available. Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[103553083]
In this event it was reported that a paste filler separated. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
[119717843]
The paste filler returned in loose is actually broken at the base of the active part. No material defect was found during analysis of the rupture pattern. Nothing unusual to report was found during dhrs review. Unused instruments were measured and were found in compliance with specifications. For information, no mechanical test is applicable regarding this product. Root causes are not identified. We will track this kind of event and monitor the trend. Additional information was received indicating that the broken piece was easily retrieved and no injury resulted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611053-2018-00030 |
| MDR Report Key | 7366874 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-05-22 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-03-23 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY VDW GMBH |
| Manufacturer Street | BAYERWALDSTRASSE 15 |
| Manufacturer City | MUNICH, 81737 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROOT FILLER L |
| Generic Name | INSTRUMENT, FILLING, PLASTIC, DENTAL |
| Product Code | EIY |
| Date Received | 2018-03-23 |
| Returned To Mfg | 2018-02-23 |
| Model Number | NA |
| Catalog Number | V040393021030 |
| Lot Number | 103253 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |