MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SPINE GUIDANCE SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6002-710-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the spine guidance 4 software, the navigation was inaccurate which resulted in the surgeon misplacing the guide wire.The surgeon redid the guide wire placement and the procedure was completed successfully with a surgical delay of 40 minutes.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Corrected data: b2 and g1.Additional data: h4.
Event or Problem Description
It was reported that during a case using the spine guidance 4 software, the navigation was inaccurate which resulted in the surgeon misplacing the guide wire.The surgeon redid the guide wire placement and the procedure was completed successfully with a surgical delay of 40 minutes.

• Brand Name: SPINE GUIDANCE SOFTWARE
• Common Device Name: ORTHOPEDIC 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: 21355847
• Report Number: 0008010177-2025-00019
• Device Sequence Number: 9003583
• Product Code: OLO
• UDI-Device Identifier: 07613327545883
• UDI-Public: 07613327545883
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220593
• 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): 03/18/2025

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: 6002-710-000
• Device Lot Number: SOFTWARE VERSION UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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