FDA Adverse Event
Injury
Summary report: N
NX3
MDR report key: 3926508
·
Received July 10, 2014
Report
- Report Number
- 2024312-2014-00499
- Event Type
- Injury
- Date Received
- July 10, 2014
- Report Date
- June 18, 2014
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K062519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PATIENT SPECIFICS WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE DOCTOR TOOK AN IMPRESSION AN HOUR AFTER CEMENTATION OF CROWNS FOR TOOTH #3 AND #4. UPON REMOVAL OF THE IMPRESSION, CROWN FOR TOOTH #3 HAD DEBONDED. THE PATIENT RETURNED THE FOLLOWING DAY AND A CROWN FOR TOOTH #4 HAD DEBONDED WHILE THE ASSISTANT WAS USING A WATER PIK. THE DOCTOR RE-CEMENTED THE CROWNS WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.
Description of Event or Problem · 1
A DOCTOR'S OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF CROWNS AFTER PLACEMENT WITH NX3 CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403282 | NX3 | DENTAL CEMENT | EMA | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | SILANE| TAKE 1 ADVANCED| OPTIBOND |