MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC.

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted late due to an unexpectedly high volume of complaints from an international distributor on 1-13-20.The fda was made aware of the high volume of complaints by glidewell.Email response received from the fda on 2-5-20.The patient's race and ethnicity were not provided; however, the patient's nationality is listed as (b)(6).The device information was not provided.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 : 3011649314-2020-00147.

Event Description

It was reported that the implant driver failed.The patient presented on (b)(6) 2019 for implant placement on tooth #20 (universal).During the procedure the provider notes that the implant stuck into the driver.There was no harm to the patient.However, it is unclear if there was patient contact.No other information was provided.

Manufacturer Narrative

The device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: dhr reviewed; the device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: stock product reviewed results: not able to review the stock product since customer did not provide the driver's lot number.Investigation results: the device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: it was not possible to measure the reported devices and perform any fit check, nor was it possible to determine if the reported devices met the specification.Root cause: the root cause cannot be explicitly determined.Both implant and driver were not returned for investigation.There was no evidence found to indicate that the reported issue was caused by the driver.It was also unknown if the customer selected the correct type and size of the driver for implant placement.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• MDR Report Key: 9818497
• MDR Text Key: 195096061
• Report Number: 3011649314-2020-00146
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 87