MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	6000-005-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During a spinal fusion procedure at the user facility the device was tracking inaccurately, approximately 4 cm to the left, resulting in the use of an unknown non-navigated screw to complete the procedure.The initial reporter advised that there was no impact to the patient or clinically significant delays associated with the procedure.
Event or Problem Description
During a spinal fusion procedure at the user facility the device was tracking inaccurately, approximately 4 cm to the left, resulting in the use of an unknown non-navigated screw to complete the procedure.The initial reporter advised that there was no impact to the patient or clinically significant delays associated with the procedure.

• Brand Name: UNIVERSAL TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6615280
• Report Number: 0001811755-2017-01293
• Device Sequence Number: 13639916
• Product Code: OLO
• UDI-Device Identifier: 04546540245038
• UDI-Public: (01)04546540245038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: Health Professional
• Device Model Number: 6000-005-000
• Device Catalogue Number: 6000-005-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1