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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the nav3i software, there were concerns of inaccuracy.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Corrected data: d2a and d2b.
Event or Problem Description
It was reported that during a case using the nav3i software, there were concerns of inaccuracy.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Corrected data: d1, d2a, d2b, and d4.
Event or Problem Description
It was reported that during a case using the nav3i software, there were concerns of inaccuracy.

• 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: 20013822
• Report Number: 0008010177-2024-00085
• Device Sequence Number: 11852889
• Product Code: OLO
• UDI-Device Identifier: 07613327004175
• UDI-Public: 07613327004175
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172034
• 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,Followup
• Report Date (Section B): 12/09/2024

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: 6002-680-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 10/15/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/09/2024
• 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: Unknown