MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE TAPERED IMPLANT DRIVER Ø3.5/4.5 MMP, LONG

Model Number 70-1071-SRG0161

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The device was received and the evaluation is anticipated.Once the investigation is completed, a supplemental report will be submitted.

Event Description

It was reported that an inclusive tapered implant long driver failed to engage the implant.The doctor was testing the long driver with the inclusive implant prior using it on patient.The doctor thought the driver didn't fit tightly due to the driver's hex design.The doctor was using the driver with the inclusive wrench from the inclusive surgical kit.

Manufacturer Narrative

The driver was returned in the original package.The part was measured and verified to be an inclusive handpiece implant driver, long (70-1071-srg0161).The driver was confirmed to be manufactured in 2016-11 according to the dhr.The driver was measured and the results showed the key feature for implant retention was out of specification.It is possible that the root cause is the driver has worn out over the years and result in fail engagement with implant, which can be caused by excessive usage and force applied when engaging implant's components.This complaint will be kept on record for track and trending purposes.

• Brand Name: INCLUSIVE TAPERED IMPLANT DRIVER Ø3.5/4.5 MMP, LONG
• Type of Device: INCLUSIVE TAPERED IMPLANT DRIVER Ø3.5/4.5 MMP, LONG
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8044644
• MDR Text Key: 127547906
• Report Number: 3011649314-2018-00397
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0161
• Device Catalogue Number: 70-1071-SRG0161
• Device Lot Number: 6023820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1