MAUDE Adverse Event Report: IHMAX; I-HEXMRT IMPLANT 9.0 X 11MM

Model Number	15872K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: IHMAX
• Common Device Name: I-HEXMRT IMPLANT 9.0 X 11MM
• MDR Report Key: 12624845
• Report Number: 3005990499-2021-30893
• Device Sequence Number: 11848245
• Product Code: DZE
• UDI-Device Identifier: D76815872K0
• UDI-Public: +D76815872K0/$$7WO015962L
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 01/02/2026
• Device Model Number: 15872K
• Device Catalogue Number: 15872K
• Device Lot Number: WO-015962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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