MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE TIT CUSTOM ABUTMENT

Model Number ITCAHAHN2

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The patient's weight was not recorded by the doctor.The device has no serial number, lot number, expiration date or udi number.The device is not an implantable device.The device was discarded by the customer and is not available for return.

Event Description

It was reported that an abutment screw broke on an inclusive ti custom abutment.The doctor reported that on (b)(6) 2021 the abutment screw broke in the implant while placing the custom abutment at tooth location #7.The patient returned on (b)(6) 2021 and had the broken portion of the screw removed from the implant.The custom abutment was then placed with a new abutment screw.The patient is currently reported to be doing well with the new custom abutment.The patient has type ii bone quality, and has no relative medical or dental history.

• Brand Name: INCLUSIVE TIT CUSTOM ABUTMENT
• Type of Device: INCLUSIVE TIT CUSTOM ABUTMENT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301 dupont dr; suite 250; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2301 dupont drive; suite 250; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2301 dupont drive; suite 250; irvine, CA 92612 ; 9494402632
• MDR Report Key: 11807851
• MDR Text Key: 250329083
• Report Number: 3011649314-2021-00156
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITCAHAHN2
• Device Catalogue Number: ITCAHAHN2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR