MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for UNICORE DRILL SIZE 31 REFILL 7121 manufactured by Ultradent Products Inc..
[95852639]
Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function. Therefore, this event meets the criteria for reportability per 21 cfr part 803. After evaluation of returned drill it was determined that the drill had previously been damaged by being grasped tightly on the cutting edge by a device which may have been used to insert the drill into the hand piece. Refile due to issues with uploading to maude data base
Patient Sequence No: 1, Text Type: N, H10
[95852640]
Dentist had a #1 unicore drill break in the canal he was able to retrieve the broken portion of the drill from the tooth and proceed with procedure. Dentist reported all is fine with the tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00040 |
| MDR Report Key | 7139675 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2015-02-11 |
| Date Mfgr Received | 2015-02-11 |
| Device Manufacturer Date | 2013-09-05 |
| Date Added to Maude | 2017-12-21 |
| 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 RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8005525512 |
| Manufacturer G1 | ULTRADENT PRODUCTS |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNICORE DRILL SIZE 31 REFILL |
| Generic Name | UNICORE DRILL |
| Product Code | EJL |
| Date Received | 2017-12-21 |
| Returned To Mfg | 2015-02-23 |
| Catalog Number | 7121 |
| Lot Number | B8NYL |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC. |
| Manufacturer Address | 505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |