MAUDE Adverse Event Report: DENTSPLY DETREY GMBH CERAM-X SPECTRA; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 607.01.690

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/23/2020

Event Type  Injury  

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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.A dhr review was conducted with no discrepancies noted.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

It was reported that a (b)(6) year old male patient experienced an allergic reaction (edema of the lower lip) following a treatment including ceram.X spectra hv/lv.Due to the age of the patient and his medical background, he preferred calling the emergency service, and the patient went to the hospital.He recovered rapidly.

• Brand Name: CERAM-X SPECTRA
• 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 10602922
• MDR Text Key: 209128509
• Report Number: 8010638-2020-00007
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 607.01.690
• Device Lot Number: 0032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR