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

Model Number 70-1071-SRG0085

Device Problems Device Damaged by Another Device (2915); Failure to Eject (4010)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

The complaint device has not been returned.The investigation is currently ongoing.Once the investigation is completed, a supplemental report will be submitted.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported that there was a driver fracture.The patient's bone quality is type i and their oral hygiene is noted as good.The patient is an ex-smoker and has a history of diabetes.On (b)(6) 2024, the patient presented for primary procedure on tooth # 3.During implant placement, the provider found the driver fractured and it was stuck in the implant.At that time, the driver and implant were removed from the patient and the implant was replaced with a similar product.

• Brand Name: HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: shelly gallup ; 2144 michelson drive; irvine, CA 92612 ; 9492223590
• MDR Report Key: 19000041
• MDR Text Key: 338902395
• Report Number: 3011649314-2024-00195
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/28/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White