MAUDE Adverse Event Report: Keystone Dental, Inc. DYMIC; Dynamic Implant SP 5x11.5

Model Number	21-70014
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: DYMIC
• Common Device Name: Dynamic Implant SP 5x11.5
• 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 ; +1(774)210-0390
• MDR Report Key: 50909758
• Report Number: 3005990499-2026-01317
• Device Sequence Number: 14971631
• Product Code: DZE
• UDI-Device Identifier: 07290108695588
• UDI-Public: (01)07290108695588(17)300518(10)WO-032933
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/27/2026

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: 21-70014
• Device Catalogue Number: 21-70014
• Device Lot Number: WO-032933
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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: 62 YR
• Patient Sex: Female