MAUDE Adverse Event Report: DENTSPLY CAULK FLUOROCORE 2+

Catalog Number 612402

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

In this event it was reported that in 2010 several crowns had debonded causing fractures in teeth after cementation with fluorocore 2 cement.The fractured crowns and teeth were alleged to exhibit a mushy appearance inside.

Manufacturer Narrative

While it is certainly possible that the patient experienced this resulting from unset cement there potentially could be other contributing factors to teeth requiring root canal therapy after crowns are placed.It is not an uncommon occurrence that a tooth that has received a crown preparation later required root canal therapy.Often enough, the trauma from preparation of the tooth to receive the crown can cause necrosis of the nerve.In addition there is no mention of how long the patient wore provisional restorations.As provisional restoration worn over long periods of time lack the marginal integrity and seal of permanent crowns the teeth may have been traumatized from this as well.Finally, over-preparation of several of the teeth to get them in line to receive esthetically pleasing restorations could cause nerve necrosis mandating rct.As there is no way to examine the preparations, the integrity and fit of the permanent crowns or the occlusion developed by the practicing dentist we must consider that the cement may have contributed to the final outcome.While in might be argued that other factors may have contributed to the problem it is impossible to ascertain whether the failures were caused by the cement alone or at all.Without additional supporting information we cannot conclude that there was a malfunction.Nevertheless, because intervention was required, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: FLUOROCORE 2+
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer (Section G): DENTSPLY CAULK; 38 west clarke ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 3625018
• MDR Text Key: 4204853
• Report Number: 2515379-2014-00004
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083326
• 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: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 612402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention