MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-19 for MTWO NITI FILE 25MM, 10/.04, 16MM WORKING PART, STERILE V040234025010 manufactured by Dentsply Vdw Gmbh.
| Report Number | 9611053-2020-00084 |
| MDR Report Key | 9858108 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494229 |
| 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 | MTWO NITI FILE 25MM, 10/.04, 16MM WORKING PART, STERILE |
| Generic Name | FILE, PULP CANAL, ENDODONTIC |
| Product Code | EKS |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-02-18 |
| Model Number | NA |
| Catalog Number | V040234025010 |
| Lot Number | 281615 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-19 |