MAUDE Adverse Event Report: ACE SURGICAL INFINITY IHEX; DENTAL IMPLANT

Model Number	203713
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant became loose.

• Brand Name: INFINITY IHEX
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 1034 pearl st; brockton MA 02301
• MDR Report Key: 20925047
• Report Number: 1287163-2024-02378
• Device Sequence Number: 5293679
• Product Code: DZE
• UDI-Device Identifier: 00614950004652
• UDI-Public: 00614950004652
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/13/2024
• Report Date (Section F): 06/12/2024

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: 203713
• Device Catalogue Number: 203713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/12/2024