MAUDE Adverse Event Report: IMPLANT DIRECT LLC LEGACY¿4 IMPLANT; DENTAL IMPLANT

Model Number 875208

Device Problems Fracture (1260); Failure to Osseointegrate (1863); Loss of Osseointegration (2408); Device-Device Incompatibility (2919); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Fistula (1862); Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Undesired Nerve Stimulation (1980); Pain (1994); Infection, Indirect (2245); Osteolysis (2377); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Exemption number: 2012017.The total number of events being summarized is: 3984.The complaints classified as serious injury events of the dental implants have been investigated and any product issues associated with these events have not been identified.No remedial action is required at this point.The complaints classified as serious injury events of the dental implants are monitored to ensure performance of the product in the market, consistent with historical and expected performance.

Event Description

This report summarizes 3984 reported events associated with serious injury involving endosseus implants, root-forn with the product classification code, dze for this reporting quarter, october 1st, 2017 to december 31st, 2017.Listing of all device and patient problems for this reporting quarter.Device problems: failure to osseointegrate; loss of osseointegration; fracture; positioning issue (failure to achieve primary stability); user error causing device-device incompatibility; no information.Patient problems: fracture failure of implant infection inflammation pain sinus perforation bone loss dehiscence fistula nerve stimulation no information nature of the events: implant failure can be divided into two categories.Early failure (failure to osseointegrate or failure to achieve primary stability) describes the situation when an implant is placed but fails to integrate.Late or long-term failure (loss of integration) is the situation that an implant has integrated solidly, but after so passage of time, usually many months or years, bone loss happens around the implant.In these cases, the dental implant needs to be removed from the patient -- a process that is considered to be a surgical intervention to remove the implant.Dental implant fracture can happen during placement of an implant or over a period of time after placement of the implant.Most likely surgical intervention is necessitated to remove a fractured implant and placement of a new implant to replace the fractured implant.

• Brand Name: LEGACY¿4 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: evan garner ; 3050 e hillcrest dr.; thousand oaks, CA 91362
• MDR Report Key: 7222289
• MDR Text Key: 98407450
• Report Number: 3001617766-2018-00003
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307103028
• UDI-Public: 10841307103028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 01/12/2022
• Device Model Number: 875208
• Device Catalogue Number: 875208
• Device Lot Number: 87665
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• 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): Other; Required Intervention