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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a craniotomy using the cranial map software, the accuracy was off by at least 1 centimeter.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
H6 codes have been updated to reflect the conclusion of the investigation.Corrected data: d4 additional data: h4.

• 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 ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21304734
• Report Number: 0008010177-2025-00017
• Device Sequence Number: 18354970
• Product Code: HAW
• UDI-Device Identifier: 07613327327199
• UDI-Public: 07613327327199
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/02/2025

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: 6000-660-000
• Device Lot Number: SOFTWARE VERSION: 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: 01/06/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 06/02/2025
• 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
• Patient Sex: Unknown