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U.S. Department of Health and Human Services

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

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DENTSPLY DETREY GMBH CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE MATERIAL, TOOTH SHADE, RESIN Back to Search Results
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 fourth 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.
 
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Brand NameCERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE
Type of DeviceMATERIAL, 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 Key6408961
MDR Text Key70072636
Report Number8010638-2017-00004
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K052097
Number of Events Reported1
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 Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number607.01.570
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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