MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT 5.0 X 8 MM

Model Number 70-1154-IMP0014

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.When the device is returned an investigation will be carried out and a supplemental report will be submitted.

Event Description

It was reported that hahn tapered implant failed.The patient has bone type ii.There is no medical or dental history prior to implant.The patient presented on (b)(6) 2018 for primary procedure on tooth #3.On (b)(6) 2021 the patient presented for follow up procedure.Upon examination the provider notes the screw was stripped internally and pieces of the screw was left in the implant.It was at that time the implant was removed.In addition the provider notes the patient had slight bone loss and the sight had to be grafted.The provider notes the patient's current status as "fine".

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: 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 reviewed results: there was no stock product from lot# 6061351 available for review.Investigation methods/results: the device was returned but not in original package.The implant was verified to be a hahn tapered implant ø5.0 x 8 mm (70-1154-imp0014) using radiographic template (pk-209-062515).The implant had defects in the threading and appeared fractured.Implant collar was also fractured and appeared structurally compromised.Implant screw was not returned for investigation.It was difficult to assess the internal threading of the implant mentioned in the complaint along with implant screw.Root cause: the root cause was inconclusive and cannot be explicitly determined.Customer did not reported any osseointegration issue.The probable cause for the fracture could be contributed by patient factors.Per the reported information, the patient had a heavy occlusion and may have contributed to the failure.

• Brand Name: HAHN TAPERED IMPLANT 5.0 X 8 MM
• Type of Device: HAHN TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301 dupont dr; suite 250; irvine CA 92612
• MDR Report Key: 11691147
• MDR Text Key: 246450498
• Report Number: 3011649314-2021-00118
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K143353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 10/18/2023
• Device Model Number: 70-1154-IMP0014
• Device Catalogue Number: 70-1154-IMP0014
• Device Lot Number: 6061351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91