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

More information will be available upon evaluation of the returned part.The evaluation is in progress.

Event Description

It was reported by a dental laboratory that a variety of abutments that they used had unbonded.Additional information was received on (b)(6) 2016 by laboratory personnel.He reported that he was having issue with the titanium abutment bonding to zirconia milling crowns.Further described as" the cement to the t-base to zirconia would separate".He stated that this had occured in the lab setting a few times( not exactly sure how many) no contact with the patient.Laboratory requested information on type of cement to use.Additional information on (b)(6) 2016: laboratory was aware of an abutment that debonded in the mouth of a patient.It was in service for one year, when he was informed that it was loose and debonded in the patient's mouth.Laboratory personnel stated that the patient did not suffer any adverse event nor injury as far as he knew and remembered.He was unable to provide any additional information regarding the incident nor collection of the doctor that reported it.He stated that there was no issue with the abutments themselves, however; the issue was with them bonding to the cement ( ivoclar multi-link cement).Therefore, he sent the unused inventory back.Lab reported they purchased a different brand of cement also.

• 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: 5832099
• MDR Text Key: 50728841
• Report Number: 0002031503-2016-00051
• 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: 06/29/2016

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: Dentist
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1