MAUDE Adverse Event Report: Maquet GmbH Traction boot, adult; Table And Attachments, Operating-Room

Model Number	10018800
Medical Device Problem Codes	Unintended Movement (3026); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Traction boot, adult
• Common Device Name: Table And Attachments, Operating-Room
• Manufacturer (Section G): Maquet GmbH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: diana gutekunst ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 50152976
• Report Number: 8010652-2026-0000047
• Device Sequence Number: 21476904
• Product Code: BWN
• UDI-Device Identifier: 04046768000056
• UDI-Public: (01)04046768000056(11)230821
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 10018800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Unknown