MAUDE Adverse Event Report: DENTSPLY DETREY GMBH CERAMX MONO+ M3 SYR REFILL; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 696022

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported that ceramx mono+ m3 syr refill that was used in course of treatment of a patient may have caused an allergic reaction in the patient.Mentioned symptoms that patient experienced: swollen and inflamed gums.The patient was treated with various materials and it is not certain which item was decisive for the allergic reaction.The dentist has therefore contacted all manufacturers whose products came into contact with the patient.It is therefore no longer possible for the practice to say which ceram x was used (shade, lot).A follow up contact determined that the allergist could not do an allergy test for dental products, but he ruled out an allergy from our composite.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Manufacturer Narrative

Investigation: no material / no lot.Investigation is not possible.Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).

• Brand Name: CERAMX MONO+ M3 SYR REFILL
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17594940
• MDR Text Key: 321633662
• Report Number: 8010638-2023-00025
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 696022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/09/2023
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1