MAUDE Adverse Event Report: CHOICESPINE, LLC ANTERIOR CERVICAL PLATE ACP SYSTEM (FALCON); FALCON SCREW,VSD,4.0X14

Model Number	FT10-BP414
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) performed a 2-level acdf on a patient on (b)(6) 2021.In this case, he implanted another company's interbody device with the falcon plate.The patient came in for an unscheduled 14-month postoperative follow-up visit.X-rays taken during the 14-month postop visit revealed that one of the bottom screws completely dislodged from the falcon plate and was in soft tissue.Dr.(b)(6) re-operated on the patient and removed the dislodged screw and left the rest of the hardware untouched.Dr.(b)(6) relayed to (b)(6) (his rep) that there were no complaints from the patient at the 12-month visit.
Additional Manufacturer Narrative
A definitive root cause cannot be determined at this time.Screw over angulation, screw not seated properly, and patient injury can cause excessive stress on the clip which has been shown to cause failure of the locking mechanism and allow the screws to back out.Another possibility is that the patient had poor bone quality that did not allow for adequate bone purchase of the screw.Field feedback will continue to be assessed to determine if it becomes a reoccurring issue.

• Brand Name: ANTERIOR CERVICAL PLATE ACP SYSTEM (FALCON)
• Common Device Name: FALCON SCREW,VSD,4.0X14
• 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: 16198191
• Report Number: 3005819474-2022-00006
• Device Sequence Number: 6066391
• Product Code: KWQ
• UDI-Device Identifier: 00840996115728
• UDI-Public: 00840996115728
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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
• Device Model Number: FT10-BP414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 01/18/2023
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male