MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INFINITY DENTAL IMPLANT SYSTEM; TRICAM IMPLANT

Model Number 305011

Device Problems Failure to Interrogate (1332); Implant, removal of (2320)

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

Event Date 11/07/2013

Event Type  Injury  

Event Description

Dental implant failure to integrate.Implant was mobile and painful at uncovering stage.Bone quality at time of implant type iii.Primary stability was achieved, but no osseointegration.Augmentation performed with nuoss.Site location 14.

• Brand Name: INFINITY DENTAL IMPLANT SYSTEM
• Type of Device: TRICAM IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 3642075
• MDR Text Key: 19586632
• Report Number: 1287163-2014-00005
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: 305011
• Device Catalogue Number: 305011
• Device Lot Number: 12030118
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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