MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE® TAPERED IMPLANT 4.7 X 10 MM; DENTAL IMPLANT

Model Number 70-1070-IMP0011

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 01/28/2015

Event Type  malfunction  

Event Description

The dr.Reported that the apex of implant was in facial bone and that the temporary abutment cuff height was too long causng the implant to be top heavy.

• Brand Name: INCLUSIVE® TAPERED IMPLANT 4.7 X 10 MM
• 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: 4571428
• MDR Text Key: 18001756
• Report Number: 3002195199-2015-00033
• Device Sequence Number: 1
• Product Code: DZE
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2019
• Device Model Number: 70-1070-IMP0011
• Device Catalogue Number: 70-1070-IMP0011
• Device Lot Number: 6009327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2014
• 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