MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC.; DENTAL IMPLANT

Device Problem Difficult to Insert (1316)

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

Event Type  malfunction  

Event Description

It was reported that the dentist was unable to place an implant.He stated that the issue could be due to the implant or the driver.The dr.Stated that the driver is stuck to the driver.

Manufacturer Narrative

Additional information from dentist was requested but has not been received.This report will be updated when new information has been provided.

• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive suite p.; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive suite p.; irvine CA 92612
• Manufacturer Contact: brandon shepard ; 2212 dupont dr, suite p; irvine 92612 ; 9492251243
• MDR Report Key: 4571427
• MDR Text Key: 19407890
• Report Number: 3002195199-2015-00032
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1