MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. ZYGAFIX SPINAL FACET SCREW SYSTEM; SYSTEM, FACET SCREW SPINAL DEVICE

Model Number	X076-0020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments could not be performed due to the complaint implant being discarded at the surgical facility.A dhr review of the system complaint implant could not be performed due to the lot number of the device not being available.The root cause of this complaint cannot be reliably determined.The system drills and taps are approximately 8% undersized when compared to the diameter of system implants.The hole created by drilling and tapping may require additional downward force for a system implant to achieve appropriate bone purchase for final placement.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint on 8/16/2023.It was reported that a system compression screw would not attain bone purchase when attempted to be implanted in a surgical procedure.The complainant stated that the distal tip of the implant screw was not aggressive enough to function as intended.There were no known patient complications or delay in treatment associated with this complaint.The surgeon elected to perform a laminectomy during the procedure instead of utilizing an alternate system implant screw.The complaint implant was not available to be returned to the manufacturer for assessment, as it was discarded at the facility.

• Brand Name: ZYGAFIX SPINAL FACET SCREW SYSTEM
• Common Device Name: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 17750290
• Report Number: 3005031160-2023-00016
• Device Sequence Number: 7192655
• Product Code: MRW
• UDI-Device Identifier: M697X07600201
• UDI-Public: M697X07600201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K123932
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: X076-0020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 59 KG