MAUDE Adverse Event Report: BRAINLAB SE SPINE REFERENCE CLAMP (CARBON); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT

Model Number	55758
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since an additional surgery had to be performed to remove parts of the damaged spine reference clamp (carbon) that had fallen into the surgical site and remained inside the patient's body after the initial surgery.According to the surgeon (treating clinician): an additional surgery was performed due to the reported problem.All parts of the damaged spine reference clamp (carbon) that had been left in the patient's body were removed during the additional surgery.There were no further remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of the investigation.H6, h7: a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.
Event or Problem Description
A minimally invasive surgery on the lumbar spine due to a spinal stenosis at l4/l5 was performed with the aid of the display by the brainlab navigation software spine & trauma navigation 2.0.After the surgery, damage to the spine reference clamp (carbon) was discovered, which led to an additional surgery, on the same day, to remove pieces of the damaged clamp that had been left in the patient.According to the surgeon: an additional surgery was performed due to the reported problem.All parts of the damaged spine reference clamp (carbon) that had been left in the patient's body were removed during the additional surgery.There were no further remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• Brand Name: SPINE REFERENCE CLAMP (CARBON)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT
• Manufacturer (Section D): BRAINLAB SE; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB SE; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: kilonzo ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 23789471
• Report Number: 8043933-2025-00092
• Device Sequence Number: 14833234
• Product Code: OLO
• UDI-Device Identifier: 04056481139278
• UDI-Public: 04056481139278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 55758
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown