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

Model Number	205110
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to integrate.
Additional Manufacturer Narrative
Implant failed to osteointergrate.

• Brand Name: INFINITY IHEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 1034 pearl street; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL; 1034 pearl street; brockton MA 02301
• Manufacturer Contact: james weatherby ; 1034 pearl street; brockton, MA 02301 ; 8004413100
• MDR Report Key: 16436498
• Report Number: 1287163-2023-02130
• Device Sequence Number: 14234708
• Product Code: DZE
• UDI-Device Identifier: 00614950004805
• UDI-Public: 00614950004805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/24/2023

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: 205110
• Device Catalogue Number: 205110
• Device Lot Number: 22020073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Male