MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; LED DENTAL LIGHT FLEX ARM ASSEMBLY

Model Number	029-5507-00
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to midmark corporation that a dental light post came unthreaded from the trolley and fell onto patient in chair.It hit the patient in the leg.No injury occurred.
Additional Manufacturer Narrative
Based on pictures, the reported event is consistent with a previously identified issue with setup instructions not being followed.The issue has been resolved through corrective action.

• Brand Name: MIDMARK
• Common Device Name: LED DENTAL LIGHT FLEX ARM ASSEMBLY
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: kort fledderjohann ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 25565561
• Report Number: 1523530-2026-00006
• Device Sequence Number: 18712335
• Product Code: EAZ
• UDI-Device Identifier: 00841709106903
• UDI-Public: 00841709106903
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: 029-5507-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown