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	Failure of Implant (1924)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant fracture is a well documented and long term complication of dental implants which is related to fatigue and/or unfavorable loading conditions.Implant fracture risks are adequately captured in risk management documentation and are also captured in the adverse event reaction section of keystone dental's implant information for use which lists implant fracture as an anticipated outcome.No adverse trends were identified and the fracture rate is well within the expected rate of occurrence.
Event or Problem Description
Implant fracture.

• Brand Name: GNSIS
• Common Device Name: GENESIS TAPERED IMPLANT BIOSPARK 3.8X8.5
• 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: 20410648
• Report Number: 3005990499-2024-71879
• Device Sequence Number: 18138526
• Product Code: DZE
• UDI-Device Identifier: D768G211300
• UDI-Public: +D768G211300/$$3230430396797
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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: 04/29/2023
• Device Model Number: G21130
• Device Catalogue Number: G21130
• Device Lot Number: 39679
• 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: 09/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2018
• 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 Sex: Female