MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT PROSTHETIC DRIVER, LONG

Model Number 70-1153-PRC0056

Device Problem Premature Separation (4045)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Multiple follow-ups were conducted to obtain additional information; however, requested information is pending from the dentist.Reported device is in transit back to the manufacturer.Follow-up will be performed to obtain information.Once the evaluation is completed and new information is obtained, a supplemental report will be submitted.

Event Description

It was reported that a hahn tapered implant prosthetic driver failed to engage onto screw head.There was no report of injury or impact to the patient.

Manufacturer Narrative

Additional information was added to concomitant medical products - changed from no to yes and returned to manufacturer was updated to (b)(6)2018.The reported long driver was returned along with a short driver and a handle.A visual and microscopic inspection were performed on the returned drivers and handle.There were no deviations found with the reported drivers and associated handle.The critical parameters of the driverswere measured and no defects, nor non-conformities were found.A lot number was received and a device history record review (dhr) was conducted.There was no evidence discovered, to indicate that a product defect or nonconformity contributed to the issue.The part met all the criteria called for in the production router.The reported driver could engage with lab hahn cover screws without dropping.The driver was also fit-checked successfully and functioned without any issue.Based on the evaluation, the complaint could not be confirmed.This event will be tracked and trended.

• Brand Name: HAHN TAPERED IMPLANT PROSTHETIC DRIVER, LONG
• Type of Device: HAHN TAPERED IMPLANT PROSTHETIC DRIVER, LONG
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 7912835
• MDR Text Key: 122173872
• Report Number: 3011649314-2018-00348
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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: 70-1153-PRC0056
• Device Catalogue Number: 70-1153-PRC0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 12/24/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1