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

Model Number	204106
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.
Event or Problem Description
Poor bone quality.

• Brand Name: INFINITY IHEX
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SOUTHERN; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 17494306
• Report Number: 1287163-2023-54141
• Device Sequence Number: 20644621
• Product Code: DZE
• UDI-Device Identifier: 00614950004676
• UDI-Public: 00614950004676
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K10298100614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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: 204106
• Device Catalogue Number: 204106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Prefer Not To Disclose