MAUDE Adverse Event Report: DENTSPLY CAULK ZOE B AND T FILLING MATERIAL

Catalog Number 610103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

In this event a doctor reported that eight years after a restoration in a patient with zoe b&t, the material had not absorbed and had to be surgically removed.A patient had come to the dentist for an x-ray to ensure no damage happened after he hit his jaw.While reviewing the x-ray, the dentist noticed a dark spot, which he believed to be decay.The dentist stated that when he went to remove it, he found the zoe in pieces and it did not absorb.

Manufacturer Narrative

Zoe b&t is not resorbable material.Further review of the dentist's technique found that directions were not properly followed.While in might be argued that other factors may have contributed to the issue it is impossible to ascertain whether the failures were caused by the material 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: ZOE B AND T FILLING MATERIAL
• 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.; suite 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3608601
• MDR Text Key: 4155061
• Report Number: 2515379-2014-00003
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/16/2013

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 610103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention