MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT Ø3.5 X 10 MM; HAHN TAPERED IMPLANT SYSTEM

Model Number 70-1154-IMP0005

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 02/28/2024

Event Type  Injury  

Event Description

A healthcare professional reported a hahn tapered implant broke after three weeks of placement on tooth number 25.It was reported that the device was removed but was not replaced.The healthcare provider did not report any observed patient symptoms, or injury.

Manufacturer Narrative

The complaint device has been returned and the investigation is currently ongoing.At the completion of the investigation a supplemental report will be submitted with the analysis conclusion.Complaint history and product history records were reviewed; documentation indicates the product met release criteria.The probable or root cause of the event has not yet been identified.Manufacturer's internal reference number: (b)(4).

• Brand Name: HAHN TAPERED IMPLANT Ø3.5 X 10 MM
• Type of Device: HAHN TAPERED IMPLANT SYSTEM
• 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: 19068507
• MDR Text Key: 339679555
• Report Number: 3011649314-2024-00226
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 70-1154-IMP0005
• Device Catalogue Number: 70-1154-IMP0005
• Device Lot Number: 6137790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 62 YR
• Patient Sex: Male