MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE TAPERED IMPLANT 3.2 X 10MM X3.0; INCLUSIVETAPERED IMPLANT

Model Number 70-1070-IMP0036

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's race and ethnicity were not provided; however, the patient's nationality is listed as (b)(6).The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.This is the first of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2020-00013 ((b)(4)).

Event Description

It was reported that the inclusive tapered implant failed.The bone grade is noted as grade iii.The patient has no medical or dental history prior to implant.The patient presented on (b)(6) 2019 for implant placement on tooth #19.On (b)(6) 2019, the patient returned for the second stage of surgery.Upon exam, the provider notes a lack of stability.It was at that time the device was removed.The patient current status is noted as "fine.".

Manufacturer Narrative

The device was returned, but did not transfer to the investigator.However, the device investigation has been completed and the results are as follows: dhr results: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The part met all the criteria called for in the production router.Stock product reviewed results: there was no stock product from lot# 6049758 available for review.Investigation methods/results: the device was returned, but did not transfer to the investigator.Root cause: probable causes could be the lack of primary stability at the osteotomy site due to insufficient bone or poor bone quality; either the bone was too soft or the operator erred in creating an osteotomy bigger than the size of the implant diameter.Ifu 3023579 rev 3.0 (inclusive dental implant system) contains the following statement in warning section: "absolute success cannot be guaranteed.Factors such as infection, disease and inadequate bone quality and/or quantity can result in osseointegration failures following surgery or initial osseointegration.".In addition, contains the following statement in precaution section: "minimizing tissue damage is crucial to successful implant osseointegration.In particular, care should be taken to eliminate sources of infection, contaminants, surgical and thermal trauma.Risk of osseointegration failure increases as tissue trauma increases.All drilling procedures should be performed at 2000 rpm or less under continual and copious irrigation.All surgical instruments used must be in good condition and should be used carefully to avoid damage to implants or other components.Implants should be placed with sufficient stability; however, excessive insertion torque may result in implant fracture, or fracture or necrosis of the implant site.The proper surgical protocol should be strictly adhered to.".Per the reported information, the patient had type iii bone quality.It has been shown that the quality and quantity of bone available at the implant site are very important patient factors, in determining the success of dental implants.It is difficult to obtain implant anchorage in bone that is not very dense.Type iii: thin layer of cortical bone surrounding a core of dense trabecular bone.Therefore, the patient's bone quality may have been a factor.

• Brand Name: INCLUSIVE TAPERED IMPLANT 3.2 X 10MM X3.0
• Type of Device: INCLUSIVETAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9656111
• MDR Text Key: 189327556
• Report Number: 3011649314-2020-00012
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K121406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: 70-1070-IMP0036
• Device Catalogue Number: 70-1070-IMP0036
• Device Lot Number: 6049758
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 67