MAUDE Adverse Event Report: DENTSPLY DETREY GMBH CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 607.01.570

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted in this event, it is reportable per 21 cfr part 803.This report is for the third patient.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

It was reported that four patients experienced severe pain after having a filling with ceram-x universal.The clinician removed the ceram-x fillings in all four patients and replaced them with voco composite or glass ionomer (non-dentsply products).The pain disappeared within 48 hours for each patient.

• Brand Name: CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6408953
• MDR Text Key: 70071649
• Report Number: 8010638-2017-00003
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K052097
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 607.01.570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention