MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEMASK (TM) TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	6002-390-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a spinal procedure at the user facility the device was inaccurate when measuring both the medial and lateral patient landmarks leading to inaccurate screw placement.The placement was corrected and the procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: SPINEMASK (TM) TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10672909
• Report Number: 0001811755-2020-02692
• Device Sequence Number: 11445024
• Product Code: OLO
• UDI-Device Identifier: 37613252731437
• UDI-Public: 37613252731437
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 6002-390-000
• Device Catalogue Number: 6002-390-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1