MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INFINITY TRI-CAM IMPLANT SYSTEM; INFINITY TRI-CAM, DENTAL IMPLANT

Model Number 304313

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/29/2015

Event Type  Injury  

Event Description

Implant was placed and removed on (b)(6) 2015 due to the wrong size of implant used at time of surgery.Another implant of correct size was successfully placed during same surgical event.

Manufacturer Narrative

Eval of the implant determined that all the product's design specs were met.Visual examination yielded no unusual or specific flaws to the implant design.The reported event has been determined to be before restoration.This implant loss suggests that the source of the problem was likely to stem from procedural errors.Proper intended use of the implant is described in its instructions for use.

• Brand Name: INFINITY TRI-CAM IMPLANT SYSTEM
• Type of Device: INFINITY TRI-CAM, DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 4945005
• MDR Text Key: 20151521
• Report Number: 1287163-2015-00102
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103790
• 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: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 304313
• Device Catalogue Number: 304313
• Device Lot Number: 15010022
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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: 65 YR