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

Catalog Number	6000-670-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ventriculoperitoneal shunt could not be placed while using the cranial guidance software.An additional surgery was performed to successfully place the vp shunt later the same day.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion h3 other text : the reported product is software which does not have a final inspection.
Event or Problem Description
It was reported that a ventriculoperitoneal shunt could not be placed while using the cranial guidance software.An additional surgery was performed to successfully place the vp shunt later the same day.

• 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: 18564106
• Report Number: 0008010177-2024-00008
• Device Sequence Number: 8117198
• Product Code: HAW
• UDI-Device Identifier: 07613327538298
• UDI-Public: 07613327538298
• Combination Product (Y/N): N
• 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): 05/01/2024

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: UNKNOWN
• 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: 12/25/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown