MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X010-0151
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a tap broke during a tlif left l4/5, l5/s1 surgery on (b)(6) 2018.The surgery was successfully completed and there were no known patient injuries or complications.It was reported that while the physician was using the tap, the distal portion of the instrument twisted off.The instrument was returned for complaint assessment.The visual assessment of the tap showed an instrument with repeated use.The tap was broken as described by the complainant, functionality testing could not be performed.A dhr review was completed and no manufacturing anomalies were identified.The device met all required specifications prior to being released to distributable inventory.Driving the tap further than recommended by the surgical technique guide can create excessive resistance, which may result in an instrument malfunction.
Event or Problem Description
The complainant reported that a tap broke during a tlif left l4/5, l5/s1 surgery on (b)(6) 2018.The surgery was successfully completed and there were no known patient injuries or complications.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8223807
• Report Number: 3005031160-2019-00001
• Device Sequence Number: 18884927
• Product Code: HWX
• UDI-Device Identifier: M697X01001511
• UDI-Public: M697X01001511
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: X010-0151
• Device Lot Number: 3432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/07/2019
• 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