MAUDE Adverse Event Report: KEYSTONE DENTAL INC GENESIS; GENESIS TAPERED IMPLANT BIOSPARK 4.5X16

Model Number	G21142
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: GENESIS
• Common Device Name: GENESIS TAPERED IMPLANT BIOSPARK 4.5X16
• 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: ryan raymond ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283676
• MDR Report Key: 12807541
• Report Number: 3005990499-2021-31395
• Device Sequence Number: 5485247
• Product Code: DZE
• UDI-Device Identifier: D768G211420
• UDI-Public: +D768G211420/$$3220930356374
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 09/29/2022
• Device Model Number: G21142
• Device Catalogue Number: G21142
• Device Lot Number: 35637
• 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: 11/01/2021
• Initial Report FDA Received Date: 11/12/2021
• 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; Other
• Patient Sex: Unknown