MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE® MINI IMPLANT WITH O-BALL 3.0 MMD X 13 MML

Model Number 70-1068-IMP0008

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

The device is not available for return, at this time the fragmented portion remains in the patient's mouth.The doctor is not planning for removal.The x-ray provided confirmed that the o-ball had fractured from the top and the fragmented portion was still in place.However, there is not enough information to determine a cause.The lot number was unavailable; therefore, a review of the device history records could not be performed.Should additional information become available, pertinent to this event.A follow-up report will be submitted.Not going to be returned to mfg.

Event Description

It was reported that (b)(6) 2016 a patient was undergoing implant surgery on tooth location #24.When the doctor was driving the mini-implant in, the titanium o-ball shattered during implantation.Updated information was received: the doctor used a 2.4 mm pilot drill and drilled to the first line on the drill.The doctor stated that the implant was fully seated and was working like it should, until the last turn of the torque wrench.During the last turn, the ball got stuck in the torque wrench; which caused it to break off the implant and shatter.The patient was stated to be doing fine.The doctor stated that the broken implant would not be returned and an x-ray will be sent in lieu of the broken implant.Updated additional information received: the doctor stated that there has been no surgical attempt made to remove the fragment in the patient's mouth because, removing it would cause additional trauma.It was stated that the patient was doing well and that there are no plans to remove the shattered implant at this time.A lot number is unavailable.

• Brand Name: INCLUSIVE® MINI IMPLANT WITH O-BALL 3.0 MMD X 13 MML
• Type of Device: INCLUSIVE® MINI IMPLANT WITH O-BALL 3.0 MMD X 13 MML
• 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: andrea hunter ; 2212 dupont dr.; suite p; irvine, CA 92612 ; 9494402635
• MDR Report Key: 5923423
• MDR Text Key: 53782625
• Report Number: 0002031503-2016-00069
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 70-1068-IMP0008
• Device Catalogue Number: 70-1068-IMP0008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TORQUE WRENCH
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 91