MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for PILOT DRILL VPLT manufactured by Versah Llc.
[84090645]
Upon receiving the returned product, the manufacturer completed an investigation and determined that the product was made to specification with proper core diameter and outside diameter.
Patient Sequence No: 1, Text Type: N, H10
[84090646]
According to dr. (b)(6)'s office , while performing surgery the pilot drill utilized by the clinician broke. The clinician was able to retrieve the broken pilot drill 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 | 3011117802-2017-00002 |
| MDR Report Key | 6826891 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-08-03 |
| Device Manufacturer Date | 2017-02-07 |
| Date Added to Maude | 2017-08-29 |
| 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 RHONDA ALLEN |
| Manufacturer Street | 2500 WEST ARGYLE STREET SUITE 300 |
| Manufacturer City | JACKSON MI 49202 |
| Manufacturer Country | US |
| Manufacturer Postal | 49202 |
| Manufacturer Phone | 5177963932 |
| 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 | PILOT DRILL/DENTAL BUR |
| Product Code | EJL |
| Date Received | 2017-08-29 |
| Returned To Mfg | 2017-08-11 |
| Model Number | VPLT |
| Lot Number | 19993 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-29 |