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

Model Number 70-1052-COM0110

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The patient information was not provided when asked.The date of event was not provided.Implant and explant dates: this information was provided 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, but not 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.Qa inspector used a tool scope (asset #1102) and micrometer to measure the critical connecting features from scanning abutment and abutment screw (circled in red).Both parts met the specifications called for in daw 3022210 rev 3.0 (inclusive clinical scanning abut.) and daw 3001878 rev 7.0 (inclusive titanium scanning abutment screw).The detailed measurement results were recorded in red color below.Root cause: the root cause cannot be explicitly determined.Based on dhr review and the inspection results from returned parts, no product deformity or nonconformity was observed and the parts met the specification.Customer did not provide the detailed information about their choice of straumann parts.In addition, customer did not provide the radio-graphic pictures (as they mentioned) to verify the seating of the abutment.

Event Description

It was reported that the clinical scanning abutment "did not seat well." the provider notes that "it did not damage the patients implant.

• Brand Name: CLINICAL SCAN. ABUT., POST., COMPATIBLE WITH: STRAUMANN BONE LEVEL RC
• Type of Device: CLINICAL SCAN. ABUTMENT POSTERIOR
• 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: 9252027
• MDR Text Key: 195527087
• Report Number: 3011649314-2017-00518
• 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: 10/29/2019

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
• Device Model Number: 70-1052-COM0110
• Device Catalogue Number: 70-1052-COM0110
• Device Lot Number: 6045328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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