MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for CERCON BASE DISK WHITE 20 MM 66080020 manufactured by Dentsply Prosthetics.
[58134849]
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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[58134850]
A dental lab reported a possible allergic reaction a patient was experiencing from a (b)(6) unit bridge fashioned with cercon base. The patient reported experiencing a burning sensation on the tissue in the area of the bridge. Removal of the device alleviates the patient's symptoms.
Patient Sequence No: 1, Text Type: D, B5
[60947066]
The returned bridge was in the mouth for over 9 months and did not have a lot number associated to investigate further. Zirconia is not likely to cause an allergic reaction, the customer will also be informed to relay to the clinician that the patient should undergo allergy testing and also look to possible causes relating to cement used as well as stain and glaze applied to the bridge by the dental lab.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647456-2016-00001 |
| MDR Report Key | 6049469 |
| Date Received | 2016-10-21 |
| Date of Report | 2016-09-22 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DEGUDENT GMBH |
| Manufacturer Street | RODENBACHER CHAUSSEE 4 |
| Manufacturer City | HANAU, HESSEN 63457 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63457 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERCON BASE DISK WHITE 20 MM |
| Generic Name | POWDER, PORCELAIN |
| Product Code | EIH |
| Date Received | 2016-10-21 |
| Returned To Mfg | 2016-10-10 |
| Model Number | NA |
| Catalog Number | 66080020 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROSTHETICS |
| Manufacturer Address | 570 WEST COLLEGE AVENUE YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-21 |