MAUDE Adverse Event Report: ZHERMACK S.P.A. VIRTUAL XD LIGHT FAST SET MULTIPACK 16X50ML; MATERIAL, IMPRESSION

Catalog Number B803040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

As a result of this malfunction, the potential for medical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21 cfr part 803.Retain samples were evaluated and found to be out of specification for set time.A capa was opened to address the issue.

Event Description

It was reported that virtual xd impression material did not set at the same rate as the wash material that was being used in conjunction.The doctor stated it caused a chipped porcelain on a patient upon removal of the impression material.

• Brand Name: VIRTUAL XD LIGHT FAST SET MULTIPACK 16X50ML
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer (Section G): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6063478
• MDR Text Key: 58654262
• Report Number: 9614794-2016-00001
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B803040
• Device Lot Number: UL2222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIRTUAL XD 380 HEAVY BODY F
• Patient Outcome(s): Other