MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER 03.5 X 4.3 LONG

Model Number 70-1071-SRG0085

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.

Event Description

It was reported that the hahn tapered implant "failed which caused a mechanical problem with the driver." the physician provided additional information of the event.Regarding the "fitting issue" the implant driver had to be forcibly removed from the implant once it was removed from the osteotomy.In order to complete the procedure, a different driver from another hahn tapered implant kit was used and bone graft was done into the osteotomy to increase primary stability.Based on the information provider the event complaint is with the driver and the not the implant.

Manufacturer Narrative

Corrected data: type of reportable event: reported as malfunction; should be serious injury.

Manufacturer Narrative

Device history record: not able to review the dhr since customer did not provide the lot number.Returned sample: the driver was returned with an implant but not in the original package.The blood clots and bone debris can be observed from the returned devices.No blood clots or debris was observed from inside of the implant.Qa inspector inspected under tool scope and confirmed the driver had no defect or non-conformity.In addition, qa inspector used the tool scope to measure the critical parameters against dwg 3035916 rev 2.0 and found the measurement within the specification.See the green circle on drawing.Root cause: base on the investigation such as: measurement of the returned part, the root cause cannot be determined.The driver was measured and the results showed the driver functioned as intended.Driver was within specifications.This complaint will be retained for tracking and trending purposes.

• Brand Name: HAHN TAPERED IMPLANT DRIVER 03.5 X 4.3 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• MDR Report Key: 8687227
• MDR Text Key: 147616977
• Report Number: 3011649314-2019-00175
• 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,Followup
• Report Date: 09/12/2019

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
• Device Model Number: 70-1071-SRG0085
• Device Catalogue Number: 70-1071-SRG0085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 06/12/2019; 09/06/2019
• Supplement Dates FDA Received: 06/12/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1