MAUDE Adverse Event Report: XTANT MEDICAL ARANAX ANTERIOR CERVICAL PLATING SYSTEM

Model Number	T086-1200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A functionality assessment could not be performed due to condition of the device.The device was removed from distributable inventory.A dhr review was performed for the returned lot and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/16/15.The system surgical technique guide provides guidance on placement of system screws with the aid of an adjustable guide.The adjustable guide has two cylinders to guide the screwdriver for appropriate screw placement.If the shaft of the screwdriver was bent out of alignment, this could cause interference and friction with the inside of the cylinders.Additionally, a system screwdriver with a bent shaft may produce abnormal rotational force, which could contribute to the instrument malfunction.The inspection section of the system ifu provides guidance on instrument inspection to ensure that the instruments in the surgical tray are in appropriate condition to function as intended.The condition of the system screwdriver indicated that it may not have been in appropriate condition for use.It is possible that a thorough inspection prior to use may have resulted in this instrument not being used and requested for replacement.There have not been any other complaints of similar nature in the past 12 months.The company will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The company received notification on (b)(6) 2020 from a sales representative that stated the tip of a system screwdriver fractured during an acdf procedure.The fractured portion of the screwdriver was recovered, and an alternate screwdriver was used to successfully complete the procedure.There were no known patient complications associated with this complaint.A return authorization number was issued for return of the instrument, which arrived at the company for assessment on 1/05/2021.

• Brand Name: ARANAX ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: CERVICAL PLATING SYSTEM
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11143140
• Report Number: 3005031160-2021-00001
• Device Sequence Number: 13662396
• Product Code: KWQ
• UDI-Device Identifier: M697T08612001
• UDI-Public: M697T08612001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: T086-1200
• Device Lot Number: EM15J013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/08/2021
• 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: 61 YR