MalfunctionJEP
SYCAMORE WOOD WEDGES
Received Feb 18, 2026 · Event occurred Jan 20, 2026
Report 2511556-2026-00001 · MDR key 24384680
Device
Generic name
Retainer, Matrix
Manufacturer
Premier Dental Products CompanyCatalog number
9061103
Lot number
KR5662
Product problems
- Unexpected Color
Patient
NA · Unknown
- Skin Discoloration
Narrative
Description of Event or Problem
WE RECEIVED A COMPLAINT FOR DENTAL OFFICE STATING THAT THE BLUE DYE IN WEDGE APPEARED TO STAIN A PATIENT'S GUM.