MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SPINEMAP® 3D 3.1 - SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6002-680-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Spinal Column Injury (2081); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the spine map 3d 3.1 software, the navigated guide was inaccurate which resulted in incorrect screw placements.The surgeon replaced 6 out of the 8 screws with larger sized screws to correct the screw tract.There was a surgical delay of 180 minutes and the procedure was completed successfully.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Additional data: h4 corrected data: b5.
Event or Problem Description
It was reported that during a case using the spine map 3d 3.1 software, there was an inaccuracy which resulted in incorrect screw placement.It was further reported that the screw was inserted through the medial wall of the spinal cord, and that the surgeon replaced 6 out of the 8 screws with larger sized screws to correct the screw tract.There was a surgical delay of 180 minutes and the procedure was completed successfully.

• Brand Name: SPINEMAP® 3D 3.1 - 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20100600
• Report Number: 0008010177-2024-00091
• Device Sequence Number: 7870009
• Product Code: OLO
• UDI-Device Identifier: 07613327359954
• UDI-Public: 07613327359954
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K183196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 6002-680-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2018
• 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: Required Intervention
• Patient Sex: Unknown