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

Model Number 304310

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

Visual evaluation of product under 65x magnification showed no signs of physical defects.

Event Description

Threads didn't engage.Used larger size.

• Brand Name: INFINITY TRI-CAM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL; 1034 pearl st; brockton MI 02301
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 17822026
• MDR Text Key: 324319155
• Report Number: 1287163-2023-02273
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00614950005222
• UDI-Public: 00614950005222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K10379000614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 304310
• Device Catalogue Number: 304310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Prefer Not To Disclose