MAUDE Adverse Event Report: IVOCLAR VIVADENT AG TELIO CS LINK; CEMENT, DENTAL

Catalog Number 627941AN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Reaction (2414); Sensitivity of Teeth (2427)

Event Date 03/04/2015

Event Type  No Answer Provided  

Event Description

The dentist reports that 6-7 patients as well as 2 staff members complain of severe sensitivity after using the cement.There were several patients in which the cement was used as well however with no reaction.Each patient showed a pulpal reaction to the cement.In each complaint case, the patient complained of a lot of pain.A total of 3 complaints were received: (b)(4) from the same dentist.Only one patient resulted in a root canal therapy recommended by a different/new dentist.In the other patients the pain ceased once the provisional restoration and cement was replaced.

• Brand Name: TELIO CS LINK
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, 9494 ; LS 9494
• Manufacturer (Section G): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, 9494 ; LS 9494
• Manufacturer Contact: donna hartnett ; 175 pineview drive; amherst 14228 ; 7162912260
• MDR Report Key: 6001542
• MDR Text Key: 56540131
• Report Number: 9612352-2016-00005
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042846
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 08/29/2015
• Device Catalogue Number: 627941AN
• Device Lot Number: T35331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other