MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. DYCON; DYNAMIC CONICAL DENTAL IMPLANT Ø4.2MM L16MM

Model Number	24-70010
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: DYCON
• Common Device Name: DYNAMIC CONICAL DENTAL IMPLANT Ø4.2MM L16MM
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer Contact: brian lanza ; 13645 alton pkwy ste a; irvine, CA 92618 ; 7742100390
• MDR Report Key: 24724751
• Report Number: 3005990499-2026-00401
• Device Sequence Number: 10215789
• Product Code: DZE
• UDI-Device Identifier: 07290114691345
• UDI-Public: (01)07290114691345(17)281001(10)WO-027782
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 24-70010
• Device Catalogue Number: 24-70010
• Device Lot Number: WO-027782
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female