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

Model Number	X022-0240
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During surgery, the surgeon successfully implanted a pedicle screw.The surgeon experienced difficulty when trying to disengage the pedicle screw from the screwdriver.The complainant suspected that the screw had become cross-threaded.The surgeon was able to disengage the screwdriver, however, the threads on the driver fractured off upon disengagement.The screw was undamaged, and the screw cap was placed with no issues.There were no known patient complications.The screwdriver was returned for assessment; it showed signs of repeated use, and the complainant's claim was confirmed that the threads were damaged.The surgical technique guide provides guidance on how to load and disengage pedicle screws from the screwdriver.In addition to the explicit directions, the surgical technique guide includes warnings to prevent damage to the screwdriver when in use and during disengagement.It is possible that the damage to the returned drivers was a result of over-torquing the screwdriver, or not following the proper steps to disengage the pedicle screw.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.
Event or Problem Description
During surgery, the surgeon successfully implanted a pedicle screw.The surgeon experienced difficulty when trying to disengage the pedicle screw from the screwdriver.The complainant suspected that the screw had become cross-threaded.The surgeon was able to disengage the screwdriver, however, the threads on the driver fractured off upon disengagement.The screw was undamaged, and the screw cap was placed with no issues.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: 8327250
• Report Number: 3005031160-2019-00009
• Device Sequence Number: 1954527
• Product Code: HXX
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• 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): 02/11/2019

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: X022-0240
• Device Lot Number: 5911-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/11/2019
• 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