MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY SYCAMORE WOOD WEDGES; RETAINER, MATRIX

Catalog Number	9061103
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received a complaint for dental office stating that the blue dye in wedge appeared to stain a patient's gum.

• Brand Name: SYCAMORE WOOD WEDGES
• Common Device Name: RETAINER, MATRIX
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): SPOFADENTAL A.S.; markova 238; jicin hradec kralove, 506 0 1; EZ 506 01
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 24384680
• Report Number: 2511556-2026-00001
• Device Sequence Number: 21455156
• Product Code: JEP
• UDI-Device Identifier: 00348783005059
• UDI-Public: 00348783005059
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 9061103
• Device Lot Number: KR5662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown