MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO., INC. INFINITY EXTERNAL HEX DENTAL IMPLANT SYSTEM; INFINITY EXTERNAL HEX, DENTAL IMPLANT

Model Number 404008

Device Problems Inadequacy of Device Shape and/or Size (1583); Implant, removal of (2320)

Patient Problem Failure of Implant (1924)

Event Date 05/08/2015

Event Type  Injury  

Manufacturer Narrative

Records indicated that the implant met the specifications and were approved for product release.Ace surgical has not been issued the failed implant.Physical analysis cannot be performed.The reported event has been determined to be an unsuccessful placement implant failure.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.

Event Description

Primary stability was not achieved and a wider implant was placed during surgery.Bone quality at time of implant was type iii.

• Brand Name: INFINITY EXTERNAL HEX DENTAL IMPLANT SYSTEM
• Type of Device: INFINITY EXTERNAL HEX, DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO., INC.; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 5003931
• MDR Text Key: 23146089
• Report Number: 1287163-2015-00109
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K954513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 404008
• Device Catalogue Number: 404008
• Device Lot Number: 14040025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 68 YR