FDA Adverse Event Malfunction Summary report: N

PRIMA ESTH CON ZI ABUT RD 5.0X1.5MM

MDR report key: 1820088 · Received August 24, 2010

Report

Report Number: 3005990499-2010-00011
Event Type: Malfunction
Date Received: August 24, 2010
Report Date: July 28, 2010
Manufacturer: KEYSTONE DENTAL
Product Code: NHA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

VISUAL ANALYSIS CONFIRMS THAT THE DEVICE FRACTURED AT THE BASE, AND THAT THE TOP PORTION OF THE ABUTMENT HAD BEEN SIGNIFICANTLY MODIFIED. THE MOST PROBABLE CAUSE OF FRACTURE IN ZIRCONIA ABUTMENTS OCCURS IF A DRILL/BUR IS USED TO ALTER THE SHAPE. DUE TO THE INHERENT NATURE OF MATERIAL USED FOR CERAMIC ABUTMENTS, FAILURES OF THIS TYPE ARE NOT UNEXPECTED. THE ROOT CAUSE IS LIKELY ATTRIBUTED TO USER TECHNIQUE AND/OR OPERATIONAL CONTEXT. ANOTHER POTENTIAL ROOT CAUSE MAY BE ATTRIBUTED TO EXCESSIVE TORQUE FORCE USED TO SECURE ABUTMENT SCREW. A TORQUE SETTING OVER THE RECOMMENDED 30 NCM CAN RESULT IN FRACTURES AROUND THE BASE OF THE ZIRCONIA ABUTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. (B)(4).

Description of Event or Problem · 1

THE COMPLAINANT REPORTED THAT A PRIMA ZI ABUTMENT FRACTURED. THE COMPLAINANT NOTED A RESTORATION DATE OF (B)(6), 2010 . THERE WAS NO INDICATION OF THE PLACEMENT OR FRACTURE DATE. THE AGE AND SEX OF THE PATIENT IS UNKNOWN. THERE ARE NO FURTHER DETAILS OF THE EVENT FROM THE COMPLAINANT AT THIS TIME. THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRIMA ESTH CON ZI ABUT RD 5.0X1.5MM		NHA	KEYSTONE DENTAL	45083	019719

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK