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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case using the spine guidance 5 software, the screws were misplaced causing an anterior breach.There was a surgical delay of over 120 minutes and the patient experienced bleeding and blood clots.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H6 codes have been updated to reflect the conclusion of the investigation.Additional data: g1.

• 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 INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: lindsey long ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 22171583
• Report Number: 0008010177-2025-00084
• Device Sequence Number: 13065993
• Product Code: OLO
• UDI-Device Identifier: 07613327616118
• UDI-Public: 07613327616118
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 6002-810-000
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown