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

Model Number 304313

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

Patient Problem Failure of Implant (1924)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Implant did not thread in bone.Changed to a 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 MA 02301
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 19000186
• MDR Text Key: 338879916
• Report Number: 1287163-2024-02341
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00614950005246
• UDI-Public: 614950005246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K10379061495
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 304313
• Device Catalogue Number: 304313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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: 51 YR
• Patient Sex: Male