MAUDE Adverse Event Report: KEYSTONE DENTAL INC GENESIS; GENESIS TAPERED IMPLANT BIOSPARK 3.8X 16

Model Number	G21135
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: GENESIS
• Common Device Name: GENESIS TAPERED IMPLANT BIOSPARK 3.8X 16
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11616820
• Report Number: 3005990499-2021-27127
• Device Sequence Number: 3099257
• Product Code: DZE
• UDI-Device Identifier: D768G211350
• UDI-Public: +D768G211350/$$322073135133$
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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 Model Number: G21135
• Device Catalogue Number: G21135
• Device Lot Number: 35133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention