MAUDE Adverse Event Report: MIDMARK CORPORATION ULTRA TRIM DENTAL CHAIR; MIDMARK ULTRA TRIM DENTAL CHAIR

Model Number	153758-003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On april 11, 2025, it was reported to midmark corporation that the back of a dental chair detached from the base.No injury was indicated to patient.Per the service note, the shoulder bolts that hold the backrest at the side of the chair, behind the touch pad controls, became unthreaded.Due to having previously reporting like incidents, midmark corporation has complied to file this instance.
Additional Manufacturer Narrative
The device malfunction described in this report has been remedied by means of a corrective and preventive action on this device.The build date of this device was prior to implementation of the corrective and preventive action.No further concerns at the time of this report.

• Brand Name: ULTRA TRIM DENTAL CHAIR
• Common Device Name: MIDMARK ULTRA TRIM DENTAL CHAIR
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 21959435
• Report Number: 1523530-2025-00003
• Device Sequence Number: 7227431
• Product Code: NRU
• UDI-Device Identifier: 00841709108976
• UDI-Public: 00841709108976
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Model Number: 153758-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown