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

Catalog Number	6000-670-000
Medical Device Problem Codes	Imprecision (1307); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, during an em registration, points were picked that were roughly 2mm average and indicated it was necessary to surface trace.They restarted with 130 points, this was not enough and accuracy was still off.After further surface tracing accuracy was still off.The customer surface traced up to almost 500 points and accuracy was still off.The customer then repicked points and proceeded again with registration and surface tracing where accuracy was acceptable.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d3, d5, and g1.D9 and h6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
Per the customer, during an em registration, points were picked that were roughly 2mm average and indicated it was necessary to surface trace.They restarted with 130 points, this was not enough and accuracy was still off.After further surface tracing accuracy was still off.The customer surface traced up to almost 500 points and accuracy was still off.The customer then repicked points and proceeded again with registration and surface tracing where accuracy was acceptable.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d1, d4, and g4.
Event or Problem Description
Per the customer, during an em registration, points were picked that were roughly 2mm average and indicated it was necessary to surface trace.They restarted with 130 points, this was not enough and accuracy was still off.After further surface tracing accuracy was still off.The customer surface traced up to almost 500 points and accuracy was still off.The customer then repicked points and proceeded again with registration and surface tracing where accuracy was acceptable.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: CRANIAL GUIDANCE SOFTWARE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg MI D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17719636
• Report Number: 3015967359-2023-01937
• Device Sequence Number: 7213027
• Product Code: HAW
• UDI-Device Identifier: 07613327503265
• UDI-Public: 07613327503265
• 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,Followup
• Report Date (Section B): 01/22/2025

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: 08/17/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 03/12/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/23/2024; 01/22/2025
• 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