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

Model Number	X022-0042
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments could not be performed due to the implants not being available to be returned for complaint assessment.The threading of a system pedicle screw and cap could be damaged if excessive force was applied to the threaded interface.It may be possible to apply excessive force to the threaded interface that would damage threading if the system rod was not adequately contoured or if it were not appropriately reduced.If a system rod was not adequately contoured or appropriately reduced, it may prevent the cap from threading into the cup of the system pedicle screw as intended.The complainant was unable to confirm if the system rod was a contributing factor to threading damage and added, "i cannot say whether a system rod prevented the locking cap from engaging, it may have played a part or it may not." the root cause of this complaint cannot be reliably determined.The complaint investigation suggests the possibility that the system rod was not adequately contoured or not appropriately reduced prior to final tightening of the cap.
Event or Problem Description
The company received notification on 10/09/2020 from a foreign distributor that reported a product complaint that occurred during a surgical procedure on (b)(6) 2020.It was reported that two system final locking caps would not lock into the threading of two system pedicle screw.The complainant stated that, "it appears that the thread on the screw head and/or locking cap is damaged/faulty." there were no known patient complications or delay in treatment.The procedure was successfully completed, the complaint pedicle screw and caps were removed and replaced without incident.The following reports are associated with this submission: 3005031160-2020-00029, 3005031160-2020-00030, 3005031160-2020-00031.

• 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: 10802876
• Report Number: 3005031160-2020-00025
• Device Sequence Number: 14191496
• Product Code: MNH
• UDI-Device Identifier: M697X02200421
• UDI-Public: M697X02200421
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K120832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: X022-0042
• Device Lot Number: 13267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/06/2020
• 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: 75 YR