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

Model Number	6002-690-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility there was an inaccuracy when navigating a needle using the device's software and a spine mask as the patient tracker.K-wires were misplaced through the pedicles during the procedure and needed repositioning prior to screw implantation.Use of navigation was aborted and the procedure was completed using fluoroscopy equipment for image guidance.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a procedure at the user facility there was an inaccuracy when navigating a needle using the device's software and a spine mask as the patient tracker.K-wires were misplaced through the pedicles during the procedure and needed repositioning prior to screw implantation.Use of navigation was aborted and the procedure was completed using fluoroscopy equipment for image guidance.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: SPINEMAP GO - 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: 11504852
• Report Number: 3015967359-2021-00191
• Device Sequence Number: 19900213
• Product Code: OLO
• UDI-Device Identifier: 07613327412994
• UDI-Public: 07613327412994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/22/2021

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: 6002-690-000
• Device Catalogue Number: 6002-690-000
• Device Lot Number: VERSION 1.0-29/030
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1