MAUDE Adverse Event Report: KEYSTONE DENTAL GENESIS; GEN TPRD IMP BIOSPRK SURFACE 6.5X13

Model Number	G21153
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: GENESIS
• Common Device Name: GEN TPRD IMP BIOSPRK SURFACE 6.5X13
• Manufacturer (Section D): KEYSTONE DENTAL; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9324365
• Report Number: 3005990499-2019-10005
• Device Sequence Number: 19453948
• Product Code: DZE
• UDI-Device Identifier: D768G211530
• UDI-Public: +D768G211530/$$323083141332$
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: G21153
• Device Catalogue Number: G21153
• Device Lot Number: 41332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1