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	Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during optical registration for a prone, occipital-approach tumor resection case, the cranial guidance mask was used for prone lateral workflow.During the establishment of rescue points, it was reported that the accuracy was deemed good and the craniotomy was performed successfully.However, following post-operative scans, the physician reported there was "no tumor resected" and the patient was revised two days later.The revision procedure was completed successfully without a surgical delay or adverse consequences.
Event or Problem Description
The customer reported that during optical registration for a prone, occipital-approach tumor resection case, the cranial guidance mask was used for prone lateral workflow.During the establishment of rescue points, it was reported that the accuracy was deemed good and the craniotomy was performed successfully.However, following post-operative scans, the physician reported there was "no tumor resected" and the patient was revised two days later.The revision procedure was completed successfully without a surgical delay or adverse consequences.
Additional Manufacturer Narrative
Corrected data: d3, d5, g1, g4, and h4.D9 and h6 coding has been updated to reflect investigation conclusion.

• 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: 17930830
• Report Number: 3015967359-2023-02106
• Device Sequence Number: 17730082
• 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): 09/25/2024

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: 6000-670-000
• Device Lot Number: VERSION: 4.0-28/028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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: Required Intervention
• Patient Sex: Unknown