MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. GNSIS; GENESIS TAPERED IMPLANT BIOSPARK 3.5X11.5

Model Number	G21051
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant fracture.

• Brand Name: GNSIS
• Common Device Name: GENESIS TAPERED IMPLANT BIOSPARK 3.5X11.5
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer Contact: erik roman ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283490
• MDR Report Key: 21691849
• Report Number: 3005990499-2025-70482
• Device Sequence Number: 15646904
• Product Code: DZE
• UDI-Device Identifier: D768G210510
• UDI-Public: +D768G210510/$$3280930WO028165K
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: G21051
• Device Catalogue Number: G21051
• Device Lot Number: WO-028165
• 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: 02/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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: 42 YR
• Patient Sex: Female