MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SPINEMAP GO - SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6002-690-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Nerve Damage (1979); Spinal Column Injury (2081)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case using the spinemap go software, the surgeon misplaced the l4 and l5 pedicle screws which resulted in the patient experiencing durotomies and nerve injuries.
Additional Manufacturer Narrative
H6 codes have been updated to reflect the conclusion of the investigation.
Event or Problem Description
It was reported that during a case using the spinemap go software, the surgeon misplaced the l4 and l5 pedicle screws which resulted in the patient experiencing durotomies and nerve injuries.

• Brand Name: SPINEMAP GO - 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: 20518375
• Report Number: 0008010177-2024-00115
• Device Sequence Number: 7880955
• Product Code: OLO
• UDI-Device Identifier: 07613327412994
• UDI-Public: 07613327412994
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 6002-690-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/03/2025
• 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: Other
• Patient Sex: Unknown