MAUDE Adverse Event Report: KEYSTONE DENTAL INC IHMAX; I-HEXMRT IMPLANT 7.0 X 11MM

Model Number	15866K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: IHMAX
• Common Device Name: I-HEXMRT IMPLANT 7.0 X 11MM
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11829206
• Report Number: 3005990499-2021-28098
• Device Sequence Number: 4015643
• Product Code: DZE
• UDI-Device Identifier: D76815866K0
• UDI-Public: +D76815866K0/$$7WO012892N
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 15866K
• Device Catalogue Number: 15866K
• Device Lot Number: WO-012892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/14/2021
• 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
• Patient Age: 55 YR