MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT Ø5.0 X 8 MM

Model Number 70-1154-IMP0014

Device Problem Failure to Interrogate (1332)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 04/28/2021

Event Type  Injury  

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.This is the second of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2021-00460.

Event Description

It was reported that the patient presented on (b)(6) 2021 for primary tooth placement on tooth #5.The patient bone grade is noted as grade ii.The patient returned on (b)(6) 2021 with what was described as "inflammation and pain." upon exam the provider notes an infection and a failure of the device to integrate.It was at that time the device was removed.

Manufacturer Narrative

The device was returned, the investigation has been completed and the results are as follows: dhr results: the dhr was reviewed for lot# 6081288 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 reviewed results: the packaged stock product is not applicable for review since no defect was observed from the returned product.Investigation methods/results: the device was returned but not in original package.The device was verified to be a hahn tapered implant ø5.0 x 8mm (70-1154-imp0014) using radiographic template (pk-209-062515).There was no defect or non-conformity observed and the threads were intact.The complaint is verified based on the returned part(s) but cannot confirm the failure mode.There was no evidence found that indicated that the reported issue was caused by the device itself.Root cause: "failure to osseointegrate" is a common complaint in regards to implant failure.This occurs when the patient's bone does not integrate with the implant surface.The possible responses to this complaint could be attributed to various causes.Although the root cause for failure to osseointegrate is inconclusive and specific to each case, probable causes could be the loss of primary stability at the osteotomy site due to insufficient bone or poor bone quality; either the bone was too soft or the operator erred in creating an osteotomy bigger than the size of the implant diameter.Premature loading, patient's health, peri-implantitis, smoking, and lack of oral hygiene may also be contributing factors.Ifu 3027904 rev 2.0 (hahn tapered implant system) contains the following statement in precaution section surgical procedures: "minimizing tissue damage is crucial to successful implant osseointegration.In particular, care should be taken to eliminate sources of infection, contaminants, surgical and thermal trauma.Risk of osseointegration failure increases as tissue trauma increases.All drilling procedures should be performed at 2000 rpm or less under continual and copious irrigation.All surgical instruments used must be in good condition and should be used carefully to avoid damage to implants or other components.Implants should be placed with sufficient stability; however, excessive insertion torque may result in implant fracture, or fracture or necrosis of the implant site.The proper surgical protocol should be strictly adhered to." ifu 3027904 rev 2.0 (hahn tapered implant system) contains the following statement in warning section: "absolute success cannot be guaranteed.Factors such as infection, disease and inadequate bone quality and/or quantity can result in osseointegration failures following surgery or initial osseointegration." ifu 3027904 rev 2.0 (hahn tapered implant system) contains the following statement in warning section: "the implant site should be inspected for adequate bone by radiographs, palpations and visual examination.Determine the location of nerves and other vital structures and their proximity to the implant site before any drilling to avoid potential injury, such as permanent numbness to the lower lip and chin.".

• Brand Name: HAHN TAPERED IMPLANT Ø5.0 X 8 MM
• Type of Device: HAHN TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 12869145
• MDR Text Key: 281206787
• Report Number: 3011649314-2021-00461
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1154-IMP0014
• Device Catalogue Number: 70-1154-IMP0014
• Device Lot Number: 6081288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White