BruxZir Full Contour Zirconia Crown
Received Jul 27, 2026 · Event occurred Jul 13, 2026
Report 3011649314-2026-01161 · MDR key 50002627
Device
Product problems
- Break
- Adverse Event Without Identified Device or Use Problem
Patient
76 YR · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
On (b)(6) 2026, a healthcare professional reported that the BruxZir crown at tooth #18 had come off and that the patient had swallowed it. The patient's oral hygiene is fair. The crown was originally seated on (b)(6) 2024. The cementation failed, and the patient swallowed it. The patient reported the issue on (b)(6) 2026. The restorative material will be replaced with another product. The patient didn't suffer any permanent harm/injury.
Additional Manufacturer Narrative
The device has not yet been returned for analysis. The evaluation of the device is pending. Once the investigation is completed, a supplemental report will be submitted.Manufacturer Reference #: (b)(4).