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

Model Number	N60000463
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a straight pedicle probe was broken.The cap of the pedicle probe came off during a procedure while the surgeon was hammering on the proximal end of the instrument.The complainant added that as the surgeon was trying to remove the probe, the handle began to rotate relative to the shaft.There were no known patient complications.The complaint instrument was inspected and tested.The end cap on the proximal end of the instrument was missing, and there were extensive impact marks where the cap should have been.The handle was able to be removed from the shaft using moderate rotational force.It may be possible that repeated impacts on the instrument may have contributed to the malfunction.This instrument is not intended to be impacted.A dhr review was performed for the complaint instrument and there were no manufacturing anomalies identified.The instrument met all required specifications prior to being released to distributable inventory.
Event or Problem Description
The complainant reported that a straight pedicle probe was broken.The cap of the pedicle probe came off during a procedure while the surgeon was hammering on the proximal end of the instrument.The complainant added that as the surgeon was trying to remove the probe, the handle began to rotate relative to the shaft.There were no known patient 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: 8092218
• Report Number: 3005031160-2018-00035
• Device Sequence Number: 11266698
• Product Code: MNI
• UDI-Device Identifier: M697N600004631
• UDI-Public: M697N600004631
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• 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): 11/20/2018

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: No Information
• Device Model Number: N60000463
• Device Lot Number: 74692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/20/2018
• 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