MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-12-05 for PROMARK APEX LOCATOR PMKAL1 manufactured by Dentsply Vdw Gmbh.
[176834018]
The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[176834019]
In this event it was reported that a promark apex locator gave incorrect measurements; no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2019-00428 |
| MDR Report Key | 9416783 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-12-05 |
| Date of Report | 2020-03-30 |
| Date Added to Maude | 2019-12-05 |
| 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 | FORUM ENGINEERING TECHNOLOGIES (96) LTD. |
| Manufacturer Street | 1 PLATIN STR. NEW INDUSTRIAL ZONE |
| Manufacturer City | RISHON LEZION HAMERKAZ, 7565339 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7565339 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROMARK APEX LOCATOR |
| Generic Name | LOCATOR, ROOT APEX |
| Product Code | LQY |
| Date Received | 2019-12-05 |
| Model Number | NA |
| Catalog Number | PMKAL1 |
| Lot Number | NA |
| 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 | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-05 |