MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-01 for ROOT FILLER L V040393021025 manufactured by Dentsply Vdw Gmbh.
[5731799]
In this event it was reported that a paste filler separated; the broken part remained in root canal and root canal was filled. No further treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[13175666]
As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function. This event, therefore, is reportable per 21cfr part 803. Involved root fillers which were returned out from the blisters have been analyzed. One of them is actually broken in the active part and no material defect was found during analysis of the rupture pattern. The two other instruments are unscathed without visible marks of use. Nothing unusual to report was found during dhrs review. A sample of 10 unused device was measured and was found in compliance with spec. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2015-00007 |
| MDR Report Key | 4658886 |
| Report Source | 01,05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-02-20 |
| Date Mfgr Received | 2015-02-20 |
| Date Added to Maude | 2015-05-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROOT FILLER L |
| Generic Name | INSTRUMENT, FILLING, PLASTIC, DENTAL |
| Product Code | EIY |
| Date Received | 2015-04-01 |
| Returned To Mfg | 2015-03-02 |
| Catalog Number | V040393021025 |
| Lot Number | 097662 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-01 |