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

Catalog Number	6000-660-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case using the cranial map 3.0 software, the navigation was inaccurate.There was a surgical delay of 15 minutes and the patient was reported to have suffered neurological damage.
Additional Manufacturer Narrative
Additional data: d4, g1, h4.H6 codes have been updated to reflect the conclusion of the investigation.
Event or Problem Description
No additional information.

• Brand Name: CRANIALMAP 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 ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 22005495
• Report Number: 0008010177-2025-00072
• Device Sequence Number: 9099300
• Product Code: HAW
• UDI-Device Identifier: 07613327327199
• UDI-Public: 07613327327199
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162929
• 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): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6000-660-000
• Device Lot Number: 3.0-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2016
• 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