MAUDE Adverse Event Report: ACE SURGICAL SUPPLY INFINITYN TRI-CAM; DENTAL IMPLANT

Model Number	305013
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pain several days after implant placement; implant became mobile.
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnifiation shows no signs of physical defects.Cover screw attached.

• Brand Name: INFINITYN TRI-CAM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 16600287
• Report Number: 1287163-2023-02135
• Device Sequence Number: 12542276
• Product Code: DZE
• UDI-Device Identifier: 00614950002139
• UDI-Public: 00614950002139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954513
• 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): 03/23/2023

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: 305013
• Device Catalogue Number: 305013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/23/2023
• 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: 59 YR
• Patient Sex: Male