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

Model Number 09231021

Device Problems Failure to Osseointegrate (1863); Implant, removal of (2320); Implant Mobility NOS (Not otherwise specified) (2645)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 06/29/2015

Event Type  Injury  

Manufacturer Narrative

Records indicate 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 a post-placement/pre-load implant failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors and/or the lack of osseointegration.The patient's bone condition, oral hygiene, or behavior may have also contributed to the failure of the implant.The loss of integration or the non-integration of an endosseous dental implant is a known inherent risk of the procedure as described in this product's instructions for use.

Event Description

Bone loss, mobility, and peri-implantitis reported at time of failure.Infection and pain were also reported.

• Brand Name: INFINITY EXTERNAL HEX DENTAL IMPLANT SYSTEM
• Type of Device: INFINITY EXTERNAL HEX
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO.; brockton MA
• Manufacturer Contact: 1034 pearl st.; brockton, MA 02301 ; 8004413100
• MDR Report Key: 5039660
• MDR Text Key: 24532385
• Report Number: 1287163-2015-50120
• 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: 02/28/2014
• Device Model Number: 09231021
• Device Catalogue Number: 09231021
• Device Lot Number: 09030084M
• 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: 03/01/2009
• 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