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

Model Number 70-1154-IMP0006

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.When/if the device is returned for evaluation, the new information will be submitted in a supplemental report.

Event Description

It was reported that a hahn tapered implant failed.The implant was placed on (b)(6) 2018 at tooth location #12.The patient returned on (b)(6) 2020 with the crown in hand, and the implant still in place.The crown had broken off of the implant.There was no pain or trauma reported by the patient.After examination, the doctor noted that the "implant broke at the neck body junction.Screw also broke and stayed in implant".It was at that time that the implant was removed.The patient is currently reported to be waiting for healing before another implant is placed.The patient has type iii bone quality, and has no relevant medical or dental history.There was no abnormality noted with the implant itself.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: investigation methods/results: the device was not returned from customer.Customer provided images of the implant for evaluation.The implant product# could not be identified from the images but appears to be of the hahn tapered implant system.The implant has heavy defects and threads are visibly worn.The collar of the implant appears to be missing/broken from the implant and is not identifiable in the images provided.Significant amount of bone debris is embedded in the threading.The implant appears broken at the apex (collar).The dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Device history record review: 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 specifications called for in the production router.Stock product review: the packaged stock product was not available for review.Root cause: the root cause cannot be explicitly determined.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.Per the reported information, the patient had type iii bone quality.It has been shown that the quality and quantity of bone available at the implant site are very important patient factors, in determining the success of dental implants.It is difficult to obtain implant anchorage in bone that is not very dense.Type iii: thin layer of cortical bone surrounding a core of dense trabecular bone.Therefore, the patient's bone quality may have been a factor.

• Brand Name: HAHN TAPERED IMPLANT 3.5 X 11.5 MM
• Type of Device: HAHN TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 10686023
• MDR Text Key: 211568781
• Report Number: 3011649314-2020-00668
• 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: 05/18/2021

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: 02/23/2023
• Device Model Number: 70-1154-IMP0006
• Device Catalogue Number: 70-1154-IMP0006
• Device Lot Number: 6049860
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 82