MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEMAP GO - SALES DEMO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	81-81041
Medical Device Problem Codes	Image Display Error/Artifact (1304); Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Event or Problem Description
It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: SPINEMAP GO - SALES DEMO
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9175731
• Report Number: 0001811755-2019-03214
• Device Sequence Number: 11456936
• Product Code: OLO
• UDI-Device Identifier: 07613327413007
• UDI-Public: 07613327413007
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 81-81041
• Device Catalogue Number: 81-81041
• Device Lot Number: 1000354432
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1