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

Model Number	N60000470
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of a straight sounding probe broke when the surgeon was sounding.The broken portion was recovered, and the surgeon was able to successfully complete the procedure with the curved sounding probe.There were no reported patient complications.A visual assessment of the straight sounding probe showed an instrument with repeated use.The shaft of the instrument was bent in several areas and approximately 1.25" of the distal portion of the shaft was broken.A functionality assessment could not be performed due to the broken instrument shaft.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 06/18/2011.Straight sounding probes are used in a previously created hole to confirm continuity of the pedicle cortical wall for screw implant placement.The thin shaft of the probe can become misshaped and by the process of repeatedly applying excessive pressure while verifying the condition of the pedicle canal and associated bone.If the shaft of the instrument was repeatedly bent in the same area, it could contribute to the shaft of the instrument breaking.
Event or Problem Description
The complainant reported that the distal tip of a straight sounding probe broke when the surgeon was sounding.The broken portion was recovered, and the surgeon was able to successfully complete the procedure with the curved sounding probe.There were no reported 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: 8928121
• Report Number: 3005031160-2019-00041
• Device Sequence Number: 19539059
• Product Code: MNH
• UDI-Device Identifier: M697N600004701
• UDI-Public: M697N600004701
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: N60000470
• Device Lot Number: F3025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/23/2019
• 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