MAUDE Adverse Event Report: Keystone Dental, Inc. GNSIS; Genesis Tapered Implant Biospark 3.8X8.5

Model Number	G21130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant fracture.
Additional Manufacturer Narrative
The investigation is still in progress and will be updated when additional details are received from the customer.

• Brand Name: GNSIS
• Common Device Name: Genesis Tapered Implant Biospark 3.8X8.5
• 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: 50770593
• Report Number: 3005990499-2026-01276
• Device Sequence Number: 18745994
• Product Code: DZE
• UDI-Device Identifier: D768G211300
• UDI-Public: +D768G211300/$$3220930356663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/15/2026

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 Expiration Date: 09/30/2022
• Device Model Number: G21130
• Device Catalogue Number: G21130
• Device Lot Number: 35666
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2017
• 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: 41 YR
• Patient Sex: Male