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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the spine guidance 4.0 software there was an inaccuracy which was confirmed by a fluoroscopy shot.There was a surgical delay and the procedure was completed successfully with no adverse consequences.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Corrected data: b2, g1 additional data: h4.
Event or Problem Description
No additional information.

• 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 ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 21663378
• Report Number: 0008010177-2025-00033
• Device Sequence Number: 15392742
• 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): 06/30/2025

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: 4.0-55_055 #20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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