MAUDE Adverse Event Report: IVOCLAR VIVADENT AG MULTILINK AUTOMIX; DENTAL CEMENT 76E--BF,

Catalog Number 627473

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Numbness (2415)

Event Date 04/10/2015

Event Type  No Answer Provided  

Event Description

One patient suffered from paresthesia, tongue burn, cheek burn, and numbness in the time after receiving a ceramic dental restoration cemented with multilink automix.After 3 weeks the symptoms worsened and the complete restoration had to be removed.After removal of the restoration there was a relief from symptoms.((b)(4).

• Brand Name: MULTILINK AUTOMIX
• Type of Device: DENTAL CEMENT 76E--BF,
• 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, NY 14228 ; 7166910010
• MDR Report Key: 4821458
• MDR Text Key: 5896803
• Report Number: 0009612352-2015-00001
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123397
• 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: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 627473
• Device Lot Number: T14824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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