MAUDE Adverse Event Report: XTANT MEDICAL SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with minimal use, as identified by a lack of surface scratches and crisp laser markings.The screwdriver spring was intact, and the hex tip surrounding the screwdriver spring was fractured at an angle.A functionality assessment could not be performed due to the damaged condition of the returned complaint instrument, which was removed from distributable inventory.A dhr review was performed for 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 7/18/2016.It could be possible to fracture the distal tip of a system screwdriver when placing a system screw if abnormal force or excessive torque was applied to the system screwdriver.Abnormal force could be applied to the system screwdriver if it was rotated while at an angle or not fully seated in the head of a system screw.It may be possible to apply excessive torque to the system screwdriver if it was rotated beyond what is required to allow the implant spring resilient locking arm to retain the screw head.The system surgical technique guide provides guidance on placing system screws and states, "as the screw is tightened into bone, the screw head will pass through the resilient locking arm.An audible and tactile click should be noted as the screw engages the locking mechanism.Positioning of the locking tab in from of the screw shoulder should be visually confirmed." there has been one other complaint 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 3/18/2021 that the distal tip of a system screwdriver fractured when being rotated during an acdf procedure on (b)(6) 2021.The fractured portion of the instrument was recovered, and the surgical procedure was successfully completed with an available alternate instrument.There were no known patient complications or delay in treatment associated with this complaint.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11572697
• Report Number: 3005031160-2021-00004
• Device Sequence Number: 19885362
• Product Code: KWQ
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K170224
• 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): 03/25/2021

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: N60000160
• Device Lot Number: 7396-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/25/2021
• 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