MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for PILOT DRILL VPLT manufactured by Versah, Llc.
[95729514]
The event occurred in (b)(6) 2017, but the manufacturer was not made aware of the event until (b)(6) 2017; therefore, no device evaluation could be performed, as the customer had discarded the product. However despite no device evaluation, additional information was obtained from clinician on the device indicating that the clinician used the pilot drill 50 times and applied lateral pressure while preparing the osteotomy. Upon review of the device specifications and labeling for the pilot drill, it clearly outlines that the device is to be used between 12-20 times without applying lateral force while in use. Despite the extended use and lateral pressure applied on the device by the clinician and confirmation that there was no patient injury, the manufacturer is still submitting this report as the industry continues to file these events with fda.
Patient Sequence No: 1, Text Type: N, H10
[95729515]
While ordering a replacement pilot drill, the clinician's office indicated that their pilot drill broke back in (b)(6) 2017. After investigating further and discussing the incident with the clinician, it was determined that the pilot drill broke during surgery after being used 50 times with lateral force being applied. The clinician indicated that he was able to retrieve the broken pilot drill without issue. There was no patient injury, and surgery was performed as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011117802-2017-00003 |
| MDR Report Key | 7126275 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-04-15 |
| Date Mfgr Received | 2017-11-17 |
| Device Manufacturer Date | 2017-03-13 |
| Date Added to Maude | 2017-12-18 |
| 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 | RHONDA ALLEN |
| Manufacturer Street | 2500 WEST ARGYLE STREET SUITE 300 |
| Manufacturer City | JACKSON MI 49202 |
| Manufacturer Country | US |
| Manufacturer Postal | 49202 |
| Manufacturer Phone | 8447115585 |
| Manufacturer G1 | VERSAH, LLC |
| Manufacturer Street | 2500 WEST ARGYLE STREET SUITE 300 |
| Manufacturer City | JACKSON MI 49202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PILOT DRILL |
| Generic Name | DENTAL PILOT DRILL - BUR |
| Product Code | EJL |
| Date Received | 2017-12-18 |
| Model Number | VPLT |
| Lot Number | 20041-01 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERSAH, LLC |
| Manufacturer Address | 2500 WEST ARGYLE STREET SUITE 300 JACKSON MI 49202 US 49202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-18 |