MAUDE Adverse Event Report: DENTSPLY CAULK PRIME & BOND NT; AGENT, TOOTH BONDING, RESIN

Catalog Number 634352

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

In this event it was reported that a dentist observed recurrent/secondary decay during a follow-up below a composite restoration that was restored with prime & bond nt along with other materials on primary/deciduous teeth.It is alleged that extraction had been performed due to failing of the light curable dental bonding agent that was one of the component in the procedure.

Manufacturer Narrative

While it might be argued that some restoration may have failed prematurely, although impossible to ascertain whether the failures were caused by the cement alone or at all, without additional supporting info, it cannot be concluded that a malfunction occurred for sure.However, because a serious injury occurred, 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: PRIME & BOND NT
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3876387
• MDR Text Key: 17951297
• Report Number: 2515379-2014-00033
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 634352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 06/05/2014
• 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
• Treatment: GRANDIO COMPOSITION MATERIAL
• Patient Outcome(s): Required Intervention