MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE TITANIUM ABUTMENT; DENTAL ABUTMENT

Model Number ASKU

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

The device will be evaluated and inspected.More results will be available after completion of the investigation.

Event Description

Reference to the mdr number 0002031503-2016-p2016-173.It was reported that a titanium abutment, along with its crown, debonded in a patient's mouth after being in place of one year.It was loose and then fell into the mouth.Ther was no report of an adverse nor serious injury.It was reported there is no further information to report as the laboratory personnel had no recollection of the doctor reported it.

• Brand Name: INCLUSIVE TITANIUM ABUTMENT
• Type of Device: DENTAL ABUTMENT
• 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 dr.; suite p; irvine, CA 92612 ; 9492251249
• MDR Report Key: 5832121
• MDR Text Key: 50723960
• Report Number: 0002031503-2016-00052
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1