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

Model Number	204108
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant slightly infected and spinning.
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.

• Brand Name: INFINITY IHEX
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 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: 18812803
• Report Number: 1287163-2024-02334
• Device Sequence Number: 4320261
• Product Code: DZE
• UDI-Device Identifier: 00614950004683
• UDI-Public: 00614950004683
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K10298161495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/29/2024

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: 204108
• Device Catalogue Number: 204108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• 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: 79 YR
• Patient Sex: Male