MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE TAPERED IMPLANT DRIVER

Model Number ASKU

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's race and ethnicity were not provided; however, the patient's nationality is (b)(6).The implant driver's lot information was asked but unknown.Request to return reported driver for evaluation was made; however, the reported driver is continued to be used by the dentist and will not be returned.Once the investigation is completed, a supplemental report will be submitted.

Event Description

It was reported that an implant dropped from the inclusive tapered implant driver during implant placement.The implant was attempted to be placed in tooth # 18 (universal).There was no injury to the patient.Another implant was used to finish the procedure and the patient was reported to be fine.There was no abnormality noted with the implant itself.The implant driver will not be returned as it was continued to be used by the dentist with no further report of any issue.Lot information for the driver was asked but the dentist did not remember.

Manufacturer Narrative

The driver was requested to return for evaluation; however, the dentist continued to use driver and decided not to return the driver.Instead, an implant was returned along with screw and carrier; however, the returned implant was a hahn tapered implant 7.0 mm x 8 mm instead of an inclusive implant as initially reported.Multiple attempts were made to contact the reported to gain clarification without success.Based on the model of the returned device hahn tapered implant 7.0 mm x 8 mm, this implant is not designed to engage with an inclusive implant driver.It is unknown whether the doctor selected the correct choice of implant to mate with the inclusive driver as reported.However, a visual and microscopic inspection were performed on the returned implant and no defect or non-conformity were found.The device met specifications.There was no visual bone debris nor blood on the implant.This event could not be fully evaluated nor confirmed.This event will be tracked and trended.

• Brand Name: INCLUSIVE TAPERED IMPLANT DRIVER
• Type of Device: INCLUSIVE TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 7844911
• MDR Text Key: 119154193
• Report Number: 3011649314-2018-00326
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 62