MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-18 for ENDOREZ 5900 manufactured by Ultradent Products, Inc..
[95178867]
Ultradent received a letter from maude stating the following had been reported: root canal over fill of tooth #29 into inferior alveolar nerve canal and its ascending anterior loop. Preoperative diagnoses. Right inferior alveolar nerve injury. Tight netal nerve injury was foreign body present. Operative procedures: neuroplasty of th right inferior alveolar nerve and metal nerve. Exploration of right inferior alevolar and metal nerves. Removal of foreign body and material, right inferior alveolar and mental nerve. This is a refile from 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00035 |
| MDR Report Key | 7125072 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2013-08-02 |
| Date Mfgr Received | 2013-08-26 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015534529 |
| Manufacturer G1 | ULTRADENT PRODUCTS, INC. |
| 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 | 3 |
| Brand Name | ENDOREZ |
| Generic Name | ROOT CANAL FILLING RESIN |
| Product Code | KIF |
| Date Received | 2017-12-18 |
| Model Number | 5900 |
| Catalog Number | 5900 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-12-18 |