MAUDE Adverse Event Report: IVOCLAR VIVADENT AG SPEEDCEM PLUS; CEMENT, DENTAL

Catalog Number 681712WW

Device Problem Use of Device Problem (1670)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/09/2018

Event Type  Injury  

Event Description

A dentist reported that after using speedcem plus to cement crowns, 5 patients experienced bite discomfort and pulpitis with pain.Of those 5 patients 2 had to undergo endodontic treatment.The relevant batch (681712ww) met all the specifications and quality criteria for release.The information provided showed two potential application errors by the dentist, which might have contributed to the postoperative sensitivities: the zirconium oxide crowns were etched before insertion, which is not indicated.The preparation of the abutment teeth was not retentive.Doctor did not return speedcem plus material.

• Brand Name: SPEEDCEM PLUS
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, ls 9494 ; LS 9494
• Manufacturer (Section G): IVOCLAR VIVADENT, AG; bedererstrasse 2; schaan, 9494 ; LS 9494
• Manufacturer Contact: donna hartnett ; 175 pineview drive; amherst, NY 14228 ; 7166912260
• MDR Report Key: 7429052
• MDR Text Key: 105416195
• Report Number: 9612352-2018-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091019
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 681712WW
• Device Lot Number: W34777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other