MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM; FALCON 4.0X14MM SCREW

Model Number	FT10-BP414
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intra-op and post-op x-ray images were provided and reviewed for patient e.Smith.Screw fractures were confirmed in patient.It was also noted in the feedback summary that the patient (date of surgery (b)(6) 2018) experienced a possible non-union of the stealth cage which was later revised.The root cause of this incident is undetermined; however, possible causes of this include: in the case where non-union is prior to screw fracture, the plate and screw construct would be at risk of fatigue.A cage that is not sharing the compressive load would result in increased load experienced by the plate and screws.In the case where screw fracture occurred prior to cage non-union, the plate/screw construct is no longer able to apply the proper compressive loads to the cage which may result in non-union.In the case where subsidence occurs, the interbody also may not be sharing the full compressive loads which puts the screws at risk of fracture, as they can fatigue over time.
Event or Problem Description
Both screws broke between (b)(6) 2018 & (b)(6) 2021.Was revised on (b)(6) 2022.All hardware was removed with exception of broken screw tips in bone.

• Brand Name: CHOICESPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
• Common Device Name: FALCON 4.0X14MM SCREW
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 15339407
• Report Number: 3005819474-2022-00003
• Device Sequence Number: 6438914
• Product Code: KWQ
• UDI-Device Identifier: 00840996115728
• UDI-Public: 00840996115728
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FT10-BP414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 09/01/2022
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male