MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN ADVANCE TABLE; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	A-71101-SK
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that stabilizer leg hds had brakes not holding.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test.The device was observed in locked status while external force was applied under normal clinical handling conditions, specifically simulating the pressure applied during spinal surgery (e.G., screw insertion).The locking mechanism was confirmed to be mechanically functional and operating as designed.No mechanical failure or malfunction was identified.However, if the reported event were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.

• Brand Name: ALLEN ADVANCE TABLE
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24271639
• Report Number: 3006697241-2026-00044
• Device Sequence Number: 10722695
• Product Code: GDC
• UDI-Device Identifier: 00615521003081
• UDI-Public: (01)00615521003081(11)241104
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Model Number: A-71101-SK
• Device Catalogue Number: A-71101-SK
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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