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

Model Number	6002-690-000
Medical Device Problem Codes	Imprecision (1307); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a product demonstration at the user facility the device was inaccurate.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : the system log files were not available for review.
Event or Problem Description
It was reported that during a product demonstration at the user facility the device was inaccurate.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: SPINEMAP GO - SOFTWARE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11869953
• Report Number: 3015967359-2021-00945
• Device Sequence Number: 10974653
• Product Code: HAW
• UDI-Device Identifier: 07613327412994
• UDI-Public: 07613327412994
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/20/2021

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: 05/12/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1