MAUDE Adverse Event Report: KEYSTONE DENTAL INC IHMAX; I-HEXMRT IMPLANT 8.0 X 9MM

Model Number	15868K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: IHMAX
• Common Device Name: I-HEXMRT IMPLANT 8.0 X 9MM
• 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: 13361861
• Report Number: 3005990499-2022-10081
• Device Sequence Number: 11181163
• Product Code: DZE
• UDI-Device Identifier: D76815868K0
• UDI-Public: +D76815868K0/$$324063045424K
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 06/29/2024
• Device Model Number: 15868K
• Device Catalogue Number: 15868K
• Device Lot Number: 45424
• 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: 01/13/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2019
• 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: Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male