MAUDE Adverse Event Report: VOCO GMBH STRUCTUR 3; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number REF 2505

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104)

Event Date 12/10/2013

Event Type  Other  

Event Description

After placement of a temporary restoration that were made of structure 3, it came to painful inflammation.The inflammation had occurred in a total of 4 pts of different ages and gender, and decayed after 3-4 days.No interventions were required.More detailed info on the pts were not provided by the dentist.In the meantime, the pts were treated with a definitive restoration.The pts are doing well.There are no consequences for the pts revealed.

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 never received info on other incidents of this type in relation to structure 3.In summary of the evaluation of information received on this incident, the testing results and the assessment of the history of complaints regarding structure 3, we conclude that the pt's complaints were presumably iatrogenically induced.No corrective measures have been scheduled in consequence of this incident.

• Brand Name: STRUCTUR 3
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): VOCO GMBH; cuxhaven ; GM
• Manufacturer Contact: michael cyll ; anton-flettner-strasse 1-3; cuxhaven 27472 ; GM 27472 ; 9472171922
• MDR Report Key: 3608286
• MDR Text Key: 4172782
• Report Number: 8010908-2013-00001
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040769
• 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: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: REF 2505
• Device Lot Number: 1332545
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other