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

Catalog Number	6000-670-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the cranial guidance software, the accuracy was off after transferring the mask registration.After several attempts to regain accuracy, the surgeon opted to abandon navigation.The procedure was completed successfully with no impact to patient and a surgical delay of 30 minutes.
Additional Manufacturer Narrative
H6 codes have been updated to reflect the conclusion of the investigation.Corrected data: g1.
Event or Problem Description
No new 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: 21000886
• Report Number: 0008010177-2024-00141
• Device Sequence Number: 21296528
• Product Code: HAW
• UDI-Device Identifier: 07613327538298
• UDI-Public: 07613327538298
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/15/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 05/15/2025
• 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
• Patient Sex: Unknown