MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML

Model Number 70-1068-IMP0002

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned, but the investigation has not yet begun.Once the investigation has been completed a supplemental report will be submitted.This is the first implant of two, please see manufacturer report number 3011649314-2019-00182 ((b)(4)) for the second implant.

Event Description

It was reported that an inclusive mini implant o-ball 2.2 mmd x 13 mml broke after prosthetic restoration.According to the doctor, the patient was chewing food and the implant broke.There was no implant site infection or pain reported.The implant was placed into tooth # 9 on (b)(6) 2018 and was explanted on (b)(6) 2019.The implant site has type 1 bone quality.The patient was reported to be in good condition.There was no abnormality observed with the implant itself.

Manufacturer Narrative

The device was returned and evaluated.A visual inspection was performed on the returned device.The implant was returned, but missing one piece of the implant and not in the original package.The diameter and length were approximately measured and the implant was verified to be 2.2 mm x 8.0 mm.The o ball was intact.Bone debris was observed from the implant.A device history record (dhr) review showed no evidence that a product defect or non-conformity contributed to the reported issue.The device met all the criteria called for in the production router.The root cause cannot be explicitly determined.The most likely probable cause is patient factor.This complaint will be kept on record for track and trending purposes.

• Brand Name: INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML
• Type of Device: INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8696392
• MDR Text Key: 148426894
• Report Number: 3011649314-2019-00176
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K100932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: 70-1068-IMP0002
• Device Catalogue Number: 70-1068-IMP0002
• Device Lot Number: 6054387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 88