MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX Z; DENTAL HANDPIECE

Model Number X450L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  Injury  

Event Description

The push button and internal spring came off from the back cap assembly unexpectedly while inside the patient's mouth during a wisdom tooth extraction procedure.Both of the parts were recovered by the doctor and there was no injury to the patient.

• Brand Name: TI-MAX Z
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 17686638
• MDR Text Key: 322695903
• Report Number: 1422375-2023-00025
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2023,09/05/2023

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: X450L
• Device Catalogue Number: P1078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2023
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other