MAUDE Adverse Event Report: HERAEUS KULZER GMBH VENUS DIAMOND; DENTAL COMPOSITE/RESIN

Catalog Number 66048141

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient stated at last correspondence that she actually began to have the stated symptoms after a composite material by (b)(4) was used a year ago and after the recent restoration was completed with venus diamond, the symptoms became more pronounced.Our facility recommended that patient send the treating dentist a copy of the biocompatibility report and go for a follow up visit.(b)(4).The direction for use state: do not use in cases of a known allergy to any of the constituents of venus diamond.The use of this product is contraindicated in case of known of suspected allergies against (meth)acrylate compounds.This product or one of its components may in particular cases cause hypersensitive reactions.Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21cfr part 803 and out of an abundance of caution.

Event Description

Patient had a filling placed and a couple of days later she began having arthritic like symptoms.She is having pain throughout her body.She had not contacted her dds office.The patient did take the initiative to have a biocompatibility study conducted.The dental office confirmed that the patient had a restoration placed in september of 2016 with venus diamond composite material.The office had not been contacted by the patient at that time.

• Brand Name: VENUS DIAMOND
• Type of Device: DENTAL COMPOSITE/RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philip-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philip-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: amber brown ; 4315 lafayette blvd.; south bend, IN 46614-2517 ; 5742995411
• MDR Report Key: 6427827
• MDR Text Key: 70689792
• Report Number: 9610902-2017-00006
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K073554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 66048141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/23/2017
• Device Age: 6 MO
• Event Location: Other
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other