MAUDE Adverse Event Report: VOCO GMBH MERON (APPLICATION CAPSULE)

Catalog Number REF1242

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

Patient Problem Sensitivity of Teeth (2427)

Event Type  Other  

Event Description

A dentist alleged, between 6-8 weeks and 3-4 months after placement of restorations with meron, the patients experienced occlusal sensitivities with subsequent pulpitis.He said, that 7-8, but not more than 10 teeth from different patients were affected.The teeth were trepanned and root canal treatments were conducted.To our knowledge, the restaurations were not removed.The incidents occurred between autumn 2013 and summer 2014.Detailed.

Manufacturer Narrative

No product defect was found as a result of testing carried out on the material returned to us.The user's report does not contain any indication of product failure either.We have contacted the dentist to clarify the likely causes by a malfunction, failure or deterioration in the characteristics or the performance or an inadequacy in the labeling or the instructions for use of the product.A variety of treatments with the same batch were conducted without any problems.A pulp protection was not applied.We consider it unlikely that meron, causes the above mentioned symptoms when used properly.The case was assigned to the département of reclamations and documented.No reports have been received regarding other cases of this type in relation with meron.In summary of the evaluation of information received on this incident, the testing results and the assessment of the history of complaints were probably iatrogenically induced.No corrective measures have been scheduled in consequences of this incident.None products with this lot # was supplied to the united states.

• Brand Name: MERON (APPLICATION CAPSULE)
• Type of Device: NA
• Manufacturer (Section D): VOCO GMBH; cuxhaven ; GM
• Manufacturer (Section G): VOCO GMBH; anton-flettner-strasse 1-3; cuxhaven ; GM
• Manufacturer Contact: michael cyll ; anton-flettner-strasse 1-3; cuxhaven 27472 ; GM 27472 ; 4721719224
• MDR Report Key: 4454495
• MDR Text Key: 5422589
• Report Number: 8010908-2015-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: REF1242
• Device Lot Number: 1410403
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention