MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT 3.5 X 11.5 MM; HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM

Model Number 70-1154-IMP0006

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.Weight asked, but unknown; ethinicity- asked, but unknown; race - asked, but unknown.

Event Description

It was reported that a hahn tapered implant ø3.5 x 11.5 mm fractured after prosthetic restoration, within a year.The patient complained about looseness and pain and then 1/3 of the implant broke off inside his mouth.Only the gingiva, 1/3 of the implant.The crown and the other 2/3 of the implant are still inside the socket.The implant was placed into tooth # 29 on (b)(6) 2018 and was explanted on (b)(6) 2019.The patient has no medical or dental pre-existing history.

Manufacturer Narrative

The device was returned, but did not transfer to the investigator.However, the device investigation has been completed and the results are as follows: corrected data: d6: date of explant was not provided during the initial submission.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# 6048525 available for review.Investigation methods/results : customer returned the implant but lost by previous investigator during the transition due to covid-19 situation.Root cause: the root cause cannot be explicitly determined.The broken implant was not available for inspection.It was unknown if the breakage was the resulted from poor prosthetic design.It was also unknown if the osteotomy size was undersized or over-prepared prior to the implant placement.

• Brand Name: HAHN TAPERED IMPLANT 3.5 X 11.5 MM
• Type of Device: HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9844855
• MDR Text Key: 192637024
• Report Number: 3011649314-2020-00504
• 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: 04/05/2021

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: 12/15/2022
• Device Model Number: 70-1154-IMP0006
• Device Catalogue Number: 70-1154-IMP0006
• Device Lot Number: 6048525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR