MAUDE Adverse Event Report: NSK AMERICA CORP. NSK DENTAL TI-MAX Z95L, SERIAL # BBG80396; HANDPIECE, AIR-POWERED, DENTAL

Model Number TI-MAX Z95L

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994); Scar Tissue (2060)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Was having a crown installed by my dentist.Nsk ti-max z95l electric dental handpiece, serial # (b)(4), overheated and severely burned my tongue, caused severe pain and suffering, and has left a hard scar on my tongue.Still awaiting nsk dental test results.Fda safety report id# (b)(4).

• Brand Name: NSK DENTAL TI-MAX Z95L, SERIAL # BBG80396
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NSK AMERICA CORP.
• MDR Report Key: 10586048
• MDR Text Key: 208767098
• Report Number: MW5096853
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TI-MAX Z95L
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 77