MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CRANIAL GUIDANCE SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-670-000
Medical Device Problem Codes	Imprecision (1307); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the cranial guidance software, the surgeon reported that the accuracy was off by 40-50 millimeters.
Additional Manufacturer Narrative
Corrected data: b5, d4 and h4.H6 codes have been updated to reflect the conclusion of the investigation.
Event or Problem Description
No additional information.

• 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 INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: lindsey long ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21631725
• Report Number: 0008010177-2025-00031
• Device Sequence Number: 15830493
• Product Code: HAW
• UDI-Device Identifier: 07613327538298
• UDI-Public: 07613327538298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: 6000-670-000
• Device Lot Number: SOFTWARE VERSION: 4.0-54/054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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: Other
• Patient Sex: Unknown