FDA Adverse Event
Injury
Summary report: N
ENDOREZ
MDR report key: 7125072
·
Received December 18, 2017
Report
- Report Number
- 1718912-2017-00035
- Event Type
- Injury
- Date Received
- December 18, 2017
- Date of Event
- August 2, 2013
- Report Date
- December 18, 2017
- Manufacturer
- ULTRADENT PRODUCTS, INC.
- Product Code
- KIF
- PMA / PMN Number
- K071106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903702 | ENDOREZ | ROOT CANAL FILLING RESIN | KIF | ULTRADENT PRODUCTS, INC. | 5900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |