MAUDE Adverse Event Report: Stryker Leibinger Freiburg SPINE GUIDANCE 5 SOFTWARE; Orthopedic stereotaxic instrument

Catalog Number	6002-810-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the spine guidance 5 software, the trajectory was displaying lateral and did not align with the pre-planned screw.The screw appeared lateral on imaging and the screw as removed.There were no adverse consequences and the procedure was completed successfully with a surgical delay of over 30 minutes.

• Brand Name: SPINE GUIDANCE 5 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 Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg, FL D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24322643
• Report Number: 0008010177-2026-00009
• Device Sequence Number: 9523424
• Product Code: HAW
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K240662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 6002-810-000
• Device Lot Number: SOFTWARE VERSION UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 09/02/2026
• 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: Male