MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. STRAUMAN INCLUSIVE INSERTS

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.There was very little information provided for the event.Patient information: this information was not provided when asked, with the exception of sex.Date of event: this information was not provided when asked.Brand name, common device name: this information was not provided when asked.Device information: this information was not provided when asked.Initial reporter: this section is incomplete.The complete provider was not provided when asked.Device manufacture date: this information was not provided when asked.

Event Description

It was reported that the insert snapped off, part of the insert is still with the crown.Part of the insert is still in the implant which the provider had to remove.

Manufacturer Narrative

The device has not been returned.However, the non-visual device investigation has been completed and the results are as follows: dhr results.Lot number not provided - dhr could not be reviewed.Stock product reviewed results: lot number not provided - stock product could not be reviewed.Investigation methods/results : device was not returned for investigation.Attempts to gain more information, including the retrieval of the device, were made and documented in the diligence log.Root cause : a root cause for the reported issue cannot be explicitly determined.It is unknown if the provider is referring to the abutment or screw as "insert".Additionally, it is unknown if the practitioner followed the proper delivery protocols for the final restoration listed in the instructions for use.It is also unknown if the appropriate abutment was used for the region of the mouth.Probable root cause is over-torqueing, cross threading, or the abutment not being adequately secured.Per ifu 4849 rev.4.0 (inclusive tapered implants ifu), the "adverse events" section states: the following adverse effects have been observed when using prosthetic components and accessories: · the abutment screw has fractured due to application of excessive torque.· the abutment is not adequately secured due to inadequate application of torque.Per ifu 4849 rev.4.0 (inclusive tapered implants ifu), the "deliver the final restoration" section states: "seat the titanium abutment or screw-retained hybrid restoration completely into the implant, making sure that the anti-rotational features of the connection.Interface are fully engaged and the contours of the sculpted emergence profile are esthetically oriented.Insert the appropriate compatible abutment screw into the screw access hole and hand-tighten using the appropriate driver.It is strongly recommended that a radiograph of the connection site be taken to confirm complete seating of the abutment or hybrid restoration before proceeding.Using the appropriate driver in conjunction with a properly metered torque wrench, tighten the abutment or hybrid restoration to the implant manufacturer's recommended torque value." per ifu 4849 rev.4.0 (inclusive tapered implants ifu), the "warning" section states: "small-diameter implants with angled abutments are not recommended for the posterior region of the mouth.".

• Brand Name: STRAUMAN INCLUSIVE INSERTS
• Type of Device: STRAUMAN INCLUSIVE INSERTS
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• MDR Report Key: 10683691
• MDR Text Key: 214571265
• Report Number: 3011649314-2020-00681
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention