MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-10-28 for ROOT FILLER L V040393025030 manufactured by Dentsply Vdw Gmbh.
[58664795]
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 involved devices are actually broken at the base of the active part. No material defect was found during analysis of the rupture patterns. No unused root filler is available for evaluation. The batch number is unknown, dhr cannot be reviewed. Root causes are not identified. This kind of event is tracked and we monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
[58664796]
In this event it was reported that a paste filler separated; outcome is unknown as of this mdr evaluation. However, there is no indication that injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2016-00052 |
| MDR Report Key | 6063467 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-10-28 |
| Date of Report | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Date Added to Maude | 2016-10-28 |
| 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 | 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 MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| 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 | 2016-10-28 |
| Returned To Mfg | 2016-09-20 |
| Model Number | NA |
| Catalog Number | V040393025030 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-10-28 |