FDA Adverse Event Injury Summary report: N

NX3

MDR report key: 3365037 · Received September 24, 2013

Report

Report Number: 2024312-2013-00492
Event Type: Injury
Date Received: September 24, 2013
Report Date: August 26, 2013
Manufacturer: KERR CORPORATION
Product Code: EMA
PMA / PMN Number: K062519
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

PATIENT SPECIFIC INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE LOSS OF A CROWN, SHE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4810518 AND 4884702. THE DOCTOR RE-CEMENTED THE MOLAR CROWN FOR THE PATIENT USING THE SAME PRODUCTS WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WERE NOT RETURNED; THEREFORE, 'ADHESIVE STRENGTH' TEST OF THE RETAINED SAMPLES WERE EVALUATED YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO LOTS 4810518 AND 4884702.

Description of Event or Problem · 1

A DOCTOR ALLEGED THAT FOUR (4) PATIENTS HAD EXPERIENCED A LOSS OF A CROWN AFTER PLACEMENT WITH NX3, SILANE PRIMER AND OPTIBOND ALL IN ONE PRODUCTS. THIS IS THE SECOND OF FOUR (4) REPORTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
480462	NX3	DENTAL CEMENT	EMA	KERR CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	OPTIBOND ALL IN ONE\| SILANE PRIMER