MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. DYMIC; DYNAMIC IMPLANT SP 5X8

Model Number	21-70012
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate.

• Brand Name: DYMIC
• Common Device Name: DYNAMIC IMPLANT SP 5X8
• 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: 24410476
• Report Number: 3005990499-2026-00212
• Device Sequence Number: 21484876
• Product Code: DZE
• UDI-Device Identifier: 07290108695564
• UDI-Public: (01)07290108695564(17)290801(10)WO-030353
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/22/2026

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: 21-70012
• Device Catalogue Number: 21-70012
• Device Lot Number: WO-030353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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: 71 YR
• Patient Sex: Male