MAUDE Adverse Event Report: Stryker Leibinger Freiburg Cranial Guidance Software; Neurological stereotaxic Instrument

Catalog Number	6000-670-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cranial navigation procedure, the live camera feed froze during calibration and registration.Re-registration attempts were performed as accuracy was reported to be significantly off after mask registration.Re-registration failed and triggered a case cancellation message, after which the application returned to the setup page.The frozen live camera image persisted during navigation use.The procedure was completed successfully and no adverse consequences or any medical intervention were reported at intake.

• Brand Name: Cranial Guidance Software
• Common Device Name: Neurological stereotaxic Instrument
• Manufacturer (Section D): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50798610
• Report Number: 0008010177-2026-00177
• Device Sequence Number: 8900357
• Product Code: HAW
• UDI-Device Identifier: 07613327538298
• UDI-Public: 07613327538298
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Device Catalogue Number: 6000-670-000
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8900-100-000 (Stryker Q Guidance System)
• Patient Sex: Unknown