CEREC VITABLOC MARK II V55-215

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-11 for CEREC VITABLOC MARK II V55-215 manufactured by Vita Zahnfabrik.

Event Text Entries

[26773] Dr placed co's device. After 2 1/2 months, the restoration fractured and in the process cracked the pt's remaining tooth structure at the crest of the bone.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2082832-1996-00001
• MDR Report Key: 34873
• Date Received: 1996-07-11
• Date of Report: 1996-07-10
• Date of Event: 1996-04-14
• Date Facility Aware: 1996-04-20
• Report Date: 1996-07-10
• Date Added to Maude: 1996-08-05
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CEREC VITABLOC
• Generic Name: PRE MANUFACTURED DENTAL PORCELAIN
• Product Code: EIH
• Date Received: 1996-07-11
• Model Number: MARK II
• Catalog Number: V55-215
• Lot Number: UNKNOWN
• ID Number: CUSTOMER COMPLAINT 96023
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 36257
• Manufacturer: VITA ZAHNFABRIK
• Manufacturer Address: SPITALGASSE 3 POSTFACH 1338 D-079704 BAD SACKINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-07-11