MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP 3D 3.0 - SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	6002-670-000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility when trying to do an anatomical registration, the point position was not accurate and unable to be registered.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during a procedure at the user facility when trying to do an anatomical registration, the point position was not accurate and unable to be registered.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document the device was not available for evaluation h3 other text : the log files were not able to be retrieved.

• Brand Name: SPINEMAP 3D 3.0 - SOFTWARE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11570149
• Report Number: 3015967359-2021-00274
• Device Sequence Number: 17210115
• Product Code: OLO
• UDI-Device Identifier: 07613327114898
• UDI-Public: 07613327114898
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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): 10/27/2021

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: No Information
• Device Model Number: 6002-670-000
• Device Catalogue Number: 6002-670-000
• Device Lot Number: VERSION: 3.0-45
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1