MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEMAP 3D 3.0 - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6002-670-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hematoma (1884); Neuropathy (1983)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure at the user facility the surgeon using the spinemap 3.0 software to navigate for guidewire placement noted an inaccuracy issue when establishing patient landmarks, but preferred making reference to medial-lateral coordinate while using the device.After placing the guidewires, the surgeon used an x-ray scan and found that the guidewires were positioned differently than intended.It was reported the patient needed a blood transfusion, experienced a hematoma, and that the surgery was delayed for one hour.During the delay between procedures, it was reported the patient's blood pressure dropped.An additional surgery was conducted to re-position the guidewires using x-ray guidance for placement and to treat the hematoma.The revision surgery was completed successfully, no further adverse events or medical intervention has been reported.
Event or Problem Description
It was reported that during a procedure at the user facility the surgeon using the spinemap 3.0 software to navigate for guidewire placement noted an inaccuracy issue when establishing patient landmarks, but preferred making reference to medial-lateral coordinate while using the device.After placing the guidewires, the surgeon used an x-ray scan and found that the guidewires were positioned differently than intended.It was reported the patient needed a blood transfusion, experienced a hematoma, and that the surgery was delayed for one hour.During the delay between procedures, it was reported the patient's blood pressure dropped.An additional surgery was conducted to re-position the guidewires using x-ray guidance for placement and to treat the hematoma.The revision surgery was completed successfully, no further adverse events or medical intervention has been reported.
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 3D 3.0 - SOFTWARE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11015475
• Report Number: 0001811755-2020-03463
• Device Sequence Number: 14406158
• Product Code: HAW
• UDI-Device Identifier: 07613327114898
• UDI-Public: 07613327114898
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 3.0-45/046
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention