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

Model Number 70-1070-IMP0007

Device Problem Failure to Interrogate (1332)

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

Event Date 01/11/2016

Event Type  malfunction  

Event Description

The dentist reported that the implant failed to integrate.

• Brand Name: INCLUSIVE TAPERED IMPLANT
• 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: aliva das ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9492251249
• MDR Report Key: 5405466
• MDR Text Key: 37747477
• Report Number: 0002031503-2016-00002
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 05/01/2020
• Device Model Number: 70-1070-IMP0007
• Device Catalogue Number: 70-1070-IMP0007
• Device Lot Number: 6016739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 84