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

Model Number	205110
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant was dropped on the floor, never used on the patient.However, visual evaluation under 65x magnification showed no defects.
Event or Problem Description
Dropped on floor.

• Brand Name: INFINITY HEX
• 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: 16666230
• Report Number: 1287163-2023-02143
• Device Sequence Number: 17625834
• Product Code: DZE
• UDI-Device Identifier: 00614950004805
• UDI-Public: 00614950004805
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/03/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/03/2023
• 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: 41 YR
• Patient Sex: Female