MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. CLINICAL SCAN. ABUT., POST., COMPATIBLE WITH: STRAUMANN BONE LEVEL RC; CLINICAL SCAN. ABUTMENT

Model Number 70-1052-COM0110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Implant and explant date: this information is na the device investigation has been completed and the results are as follows: device history record 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.Returned sample: customer returned one clinical scan abutment with an abutment screw installed in the original package.Complaint investigator and sme separated the abutment screw from abutment and inspect under the microscope (20x).No defect or non-conformity was observed.No wear and tear of the threads was observed from the abutment screw.Returned part inspection results qa inspector used a tool scope and micrometer to measure the critical connecting features from scanning abutment and abutment screw.Both parts met the specifications called for in daw 3022210 rev 3.0 (inclusive clinical scanning abut.) and daw 3001878 rev 6.0 (inclusive titanium scanning abutment screw).The returned part was inspected and measured in comparison with the dhr.Both parts met the specification called for in the drawings.

Event Description

It was reported the abutment screw did not go all the way down.

• Brand Name: CLINICAL SCAN. ABUT., POST., COMPATIBLE WITH: STRAUMANN BONE LEVEL RC
• Type of Device: CLINICAL SCAN. ABUTMENT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9494402632
• MDR Report Key: 9263669
• MDR Text Key: 202003894
• Report Number: 3011649314-2017-00525
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1052-COM0110
• Device Catalogue Number: 70-1052-COM0110
• Device Lot Number: 6030967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1