MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG

Model Number 70-1071-SRG0085

Device Problem Material Deformation (2976)

Patient Problem Discomfort (2330)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

The information was requested, but was not provided by the customer.The implant driver has no expiration date.The reported device was received and the evaluation is anticipated.Once the investigation is completed, a supplemental report will be submitted.

Event Description

It was reported that a hahn tapered implant driver malfunctioned.The doctor reported that on (b)(6) 2019, while placing an implant at tooth location #22, the implant driver snapped during final torque.The implant driver would slip and skip off of the implant while torqueing the implant down.The implant could not be completely torqued and placed due to the malfunction of the implant driver.Therefore, the implant had to be removed.The doctor immediately placed a slightly larger implant at that tooth location.The patient experienced minor discomfort.There was no report of injury to the patient, and the patient is feeling better.The doctor reported that after closer inspection of the implant driver under a microscope, he noted that there was a flattened and deformed area where the implant driver connects to the implant.There was no abnormality noticed with the implant itself.The implant driver was manufactured on 06/16/2017, and was purchased by the doctor in (b)(6) 2017.

Manufacturer Narrative

The device was returned and evaluated.A visual and microscopic inspection were performed on the returned device.There was no fracture identified with the device, the driver was intact.It was observed that the surface of the hex was worn out and flatten.The complaint was confirmed, as a defect with a worn or deformed hex will impact torqueing of an implant.There were no other complaints reported for this lot.This event will be tracked and trended.

• Brand Name: HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine 92612
• MDR Report Key: 8402125
• MDR Text Key: 138209022
• Report Number: 3011649314-2019-00029
• 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: 06/05/2019

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 Model Number: 70-1071-SRG0085
• Device Catalogue Number: 70-1071-SRG0085
• Device Lot Number: 6044121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 68