MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6002-350-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility, the surgeon using the device for point matching registration of a lumbar spine procedure noticed the device was only showing the device in space on the screen instead of showing the device's vector/angle of approach.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 the device was discarded by the customer, no evaluation is possible.Discarded by user.
Event or Problem Description
It was reported that during a procedure at the user facility, the surgeon using the device for point matching registration of a lumbar spine procedure noticed the device was only showing the device in space on the screen instead of showing the device's vector/angle of approach.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: THORACIC PEDICLE FEELER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9404124
• Report Number: 0001811755-2019-03923
• Device Sequence Number: 16750018
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/20/2020

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: 6002-350-000
• Device Catalogue Number: 6002-350-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1