FDA Adverse Event
Injury
Summary report: N
NX3 CLEAR DUAL CURE CEMENT
MDR report key: 3024061
·
Received March 27, 2013
Report
- Report Number
- 2024312-2013-00076
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 25, 2013
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K013609
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
AN 'ADHESIVE STRENGTH' TEST WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.
Additional Manufacturer Narrative · 1
TO DATE, THE PATIENT IS DOING FINE; THE DOCTOR RECEMENTED THE CROWN USING NX3 XTR, WITHOUT FURTHER INCIDENT. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, RETAIN SAMPLES WERE EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEVIED IN REGARDS TO THIS LOT.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT AFTER THE PLACEMENT OF CROWNS WITH NX3 CLEAR DUAL CURE CEMENT, TWO (2) PATIENTS EXPERIENCED THE DEBONDING OF RESTORATIONS. THIS IS THE SECOND OF TWO (2) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126377 | NX3 CLEAR DUAL CURE CEMENT | DENTAL CEMENT | EMA | KERR CORPORATION | 4720876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | OPTIBOND XTR |