MAUDE Adverse Event Report: XTANT MEDICAL FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X070-0040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint driver showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and surface corrosion.The distal tip of the driver was fractured and there were rotational scratches surrounding the tip.A functionality assessment could not be performed due to the damaged condition of the returned driver.A dhr review was performed for the returned complaint lot 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 1/17/2011.It may be possible for the distal tip of the driver to fracture if excessive or abnormal force was applied to the driver while being used.Excessive force could be applied to the driver if the handle attached to the driver did not appropriately limit applied torque.The torque handle that was being used when the instrument malfunction occurred was also returned to the company to confirm the torque limiting capability.The handle was tested on a calibrated torque testing device and repeatedly produced results within the acceptable range.It may be possible to apply abnormal force if the driver was used at an angle, which could cause the distal tip of the driver to fracture.The rotational scratches on the driver distal tip and angled fracture suggest that the driver may not have been colinear with the implant screw when the malfunction occurred.There have not been any other complaints of similar nature received in the past 12 months.The company will continue to monitor this device for complaints from the field.
Event or Problem Description
The company received communication on (b)(6) 2021 that the distal tip of a system driver fractured when tightening a system screw during a l4-l5 plif procedure.The fractured portion of the driver was immediately removed, and the procedure was successfully completed.There were no known patient complications or delay in treatment associated with this complaint.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11457576
• Report Number: 3005031160-2021-00003
• Device Sequence Number: 11809638
• Product Code: MNI
• UDI-Device Identifier: M697X07000401
• UDI-Public: M697X07000401
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: X070-0040
• Device Lot Number: 66951R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/10/2021
• 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
• Patient Age: 77 YR
• Patient Weight: 79