MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP

Model Number 70-1070-IMP0007

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The patient's weight was not recorded by the customer.The device has not been returned.When/if the device is returned for evaluation, the new information will be submitted in a supplemental report.

Event Description

It was reported that an inclusive tapered implant failed.The implant was place on (b)(6) 2016 at tooth location #13.The patient returned on (b)(6) 2020 with the implant broken.The removal of the implant was delayed due to covid-19.The patient returned on (b)(6) 2020, and the implant was removed.The patient is currently reported to be in good condition, and is waiting for crown (final restoration).The patient has type ii bone quality, and has no relevant medical or dental history.There was no abnormality noted with the implant itself.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: investigation methods/results: the implant was returned but not in original package.The customer also returned one healing abutment and one titanium esthetic abutment with titanium screw still engaged.The implant diameter and length were approximately measured along with a comparison against radiographic template (doc# 3006704_4.0).The implant was identified as an inclusive tapered implant 3.7 mmd x 11.5 mml x 3.5 mmp (70-1070-imp0007).The implant collar was broken and partially missing, had defects and threads were worn out.Bone debris was observed on the implant.The healing abutment was identified to be an inclusive® tapered implant healing abutment 3.0 mmp x 3.2 mmd x 5 mmh (70-1069-imp0010) by measurements from a calibrated electronic caliper.The returned titanium esthetic abutment had slight deformities and product # could not accurately be determined.It was classified to be part of the inclusive tapered implant system in the family of titanium esthetic abutments.Device history record review: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The part met all the criteria called for in the production router.Stock product review: there was no stock product from lot# 6020762 available for review.Root cause: a root cause cannot be explicitly determined.It was unknown if the breakage was the resulted from poor prosthetic design.It was also unknown if the osteotomy size was undersized or over-prepared prior to the implant placement.The physician noted the implant placement was in a previously/ simultaneously grafted site which may have been a contributing factor.The physicians also mentions bone mineralization at the osteotomy site which is known to compromise the quality of bone tissue.

Manufacturer Narrative

Based on new information received from the customer on (b)(6) 2021, the following sections have been corrected: section b1: adverse event.Section b2: required intervention to prevent permanent impairment/damage.Section h1: serious injury.

• Brand Name: INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP
• Type of Device: INCLUSIVE TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 10659883
• MDR Text Key: 211059924
• Report Number: 3011649314-2020-00667
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K121406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: 70-1070-IMP0007
• Device Catalogue Number: 70-1070-IMP0007
• Device Lot Number: 6020762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/10/2020
• Supplement Dates Manufacturer Received: 05/10/2021; 05/24/2021
• Supplement Dates FDA Received: 05/18/2021; 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR