MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO. INFINITY INTERNAL HEX DENTAL IMPLANT SYSTEM

Model Number 203713

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

Patient Problem Failure of Implant (1924)

Event Date 01/26/2015

Event Type  Injury  

Manufacturer Narrative

Eval of the implant determined that all the product's design specifications were met.Visual examination yielded no unusual or specific flaws to the implant design.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

Implant was reported as a spinner and did not achieve primary stability.Bone quality at time of implant failure was type iii.

• Brand Name: INFINITY INTERNAL HEX DENTAL IMPLANT SYSTEM
• Type of Device: INFINITY INTERNAL HEX
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO.; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 4975976
• MDR Text Key: 22383563
• Report Number: 1287163-2015-00120
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 203713
• Device Catalogue Number: 203713
• Device Lot Number: 13120009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: 36 YR