MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-27 for PILOT DRILL VPLT manufactured by Versah, Llc.
[103930227]
Though there was no patient injury or impact on the intended surgery, a mdr is filed as the industry continues to file these events with fda.
Patient Sequence No: 1, Text Type: N, H10
[103930228]
According to dr (b)(6)'s office, it was discovered that the pilot drill broke after drilling into the osteotomy. When the pilot drill broke, the clinician was able to retrieve the broken piece without issue. There was no patient injury and surgery was able to be performed as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011117802-2018-00001 |
| MDR Report Key | 7374265 |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2018-03-27 |
| 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 | MS. RHONDA ALLEN |
| Manufacturer Street | 2500 WEST ARGYLE ST. SUITE 300 |
| Manufacturer City | JACKSON MI 49202 |
| Manufacturer Country | US |
| Manufacturer Postal | 49202 |
| Manufacturer Phone | 5179903255 |
| Manufacturer G1 | VERSAH, LLC |
| Manufacturer Street | 2500 WEST ARGYLE ST. 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 | PILOT DRILL / DENTAL BUR |
| Product Code | EJL |
| Date Received | 2018-03-27 |
| Model Number | VPLT |
| Lot Number | 20387-01 |
| 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 ST. SUITE 300 JACKSON MI 49202 US 49202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |