MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER 3.5 X 4.3 SMALL

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

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.

Event Description

It was reported that the implant driver snapped off inside the implant during placement.The doctor was able to somehow remove the implant and placed another implant into the site.No other information was provided by the doctor.

Manufacturer Narrative

The device has not been returned.However, the device investigation has been completed and the results are as follows: dhr results: unable to review the dhr since the lot number was not provided.Stock product reviewed results: unable to review the stock product since the lot number was not provided.Investigation methods/results: customer did not return the driver for investigation.Root cause the root cause cannot be explicitly determined since no driver or any broken piece of driver was returned for investigation.It is unknown if the physician followed ifu 3034554 rev 1.0 (hahn tapered implant system) correctly for implant placement.The implant driver can be broken due to the excess force applied by the user (lateral, vertical, shear, torsional, compressive angular).This event has been logged and saved for tracking and trending purposes.

• Brand Name: HAHN TAPERED IMPLANT DRIVER 3.5 X 4.3 SMALL
• Type of Device: HAHN TAPERED IMPLANT DRIVER 3.5 X 4.3 SMALL
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9844879
• MDR Text Key: 191994294
• Report Number: 3011649314-2020-00503
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: 02/26/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR