MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CRANIALMAP SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6000-660-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility, an inaccuracy of 10-20 millimeters was observed when the customer changed from using one pointer to a different pointer.The position of the tumor appeared shift.The hole on the skull was expanded to address the shift.The customer reported "large" bleeding, but additional blood transfusion was not required.No medical intervention was reported, and there were no adverse consequences.The procedure was completed successfully without a clinically significant delay.
Event or Problem Description
It was reported that during a procedure at the user facility, an inaccuracy of 10-20 millimeters was observed when the customer changed from using one pointer to a different pointer.The position of the tumor appeared shift.The hole on the skull was expanded to address the shift.The customer reported "large" bleeding, but additional blood transfusion was not required.No medical intervention was reported, and there were no adverse consequences.The procedure was completed successfully without a clinically significant delay.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: CRANIALMAP SOFTWARE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10483484
• Report Number: 0001811755-2020-02291
• Device Sequence Number: 19848655
• Product Code: HAW
• UDI-Device Identifier: 07613327327199
• UDI-Public: 07613327327199
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 6000-660-000
• Device Catalogue Number: 6000-660-000
• Device Lot Number: 16312
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1