MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADAPTER FOR HEAD POSITIONING; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1739994
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection by a field service technician, it was noticed, that there were damages to the side rails where the adapter was fixed at the operating table.Further investigation identified that under certain circumstances the adapter can be placed in a position where it could not be fixed correctly and may come loose when pulling on it.The adapter cannot come loose by itself, only by an impact (e.G.Pulling, positioning).If any new information is identified it will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report stating that during a procedure, an adapter for head positioning slipped off the standard upper back plate rail when placing a patient.The patient was uninjured, and the procedure was finished without incident.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
According to ifu doc.(b)(4) rev.05, section 6.1.1 states that the product is only authorized for use on the ts7000 and on the upper back plate h.When used on the upper back plate, attaching the adapter causes the holder to slip onto a bar behind the standard rail.This results in a very small surface area for clamping and securing the adapter.Pulling or moving the adapter can cause it to slip off the standard rail even it is tightened.The device was visual and functional inspected.The result was that the standard rail was damaged.The cause of the issue was that the adapter slipped from the rail.The adapter was replaced.

• Brand Name: ADAPTER FOR HEAD POSITIONING
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24497847
• Report Number: 3007143268-2026-00011
• Device Sequence Number: 9870054
• Product Code: GDC
• UDI-Device Identifier: 00887761972780
• UDI-Public: (01)00887761972780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 1739994
• Device Catalogue Number: 1739994
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown