MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE DRILL EXTENDER

Model Number 70-1071-SRG0014

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Expiration date: this device has no expiration date.This device is not an implantable device.The device has not been returned.When/if the device is returned for evaluation, the new information will be submitted in a supplemental report.

Event Description

It was reported that an inclusive drill extender does not hold drills firmly.The doctor reported that drills fall off (out) of this drill extender easily with gravity.There was no patient contact reported.

Manufacturer Narrative

The device has not been returned.However, the device investigation has been completed and the results are as follows: device history results: the dhr from lot# 6069352 was reviewed and the receiving lot# 01252258 passed all inspection, no product defect or non-conformity was reported.The certificate of conformance was provided by the supplier (integrity).Stock product results: there was no stock product from lot# 01252258 available for review.Returned sample(s)/device results: customer did not return the device for investigation.Investigation results: since no device was available for investigation, there was no evidence found to indicate that the reported issue was caused by the device itself root cause: the root cause cannot be explicitly determined.The device was not returned for inspection or measurement.According to the router, the drill met the current released criteria without any issue.Conclusion summary the complaint is unable to be evaluated.

• Brand Name: INCLUSIVE DRILL EXTENDER
• Type of Device: INCLUSIVE DRILL EXTENDER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8798615
• MDR Text Key: 151569606
• Report Number: 3011649314-2019-00331
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0014
• Device Catalogue Number: 70-1071-SRG0014
• Device Lot Number: 6069352
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1