MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM SOLA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11291455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	04/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.
Event or Problem Description
Siemens healthineers was notified of a serious injury associated with a magnetom sola system.It was communicated that during an mr brain examination, the patient was injured as the table was exiting the bore.The technologist stated that the patient sustained a humeral fracture while the table was being moved out of the bore.Facility physicians were required to intervene, and the patient must undergo surgical treatment for the fracture.

• Brand Name: MAGNETOM SOLA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 24981455
• Report Number: 3002808157-2026-00013
• Device Sequence Number: 18566514
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: (01)04056869164809
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K252383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown