MAUDE Adverse Event Report: CHOICESPINE, LLC THUNDERBOLT MINIMALLY INVASIVE AND LANCER OPEN PEDICLE SCREW SYSTEM; THUNDERBOLT/LANCER NEW SET SCREW THREAD

Model Number	MT20-0002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient original surgery date was (b)(6) 2022.First surgery l3-4, l4-5 dlif/l5-s1 alif/l3, l4, l5, s1 psf.The set screws came out bilaterally s1 and left l5.The l5-s1 cage had also migrated & had to be replaced.The revision surgery was done on (b)(6) 2023.Screw & set screws were sent to (b)(4) on (b)(6) 2023.
Additional Manufacturer Narrative
We have reviewed the returned pedicle screws and set screws.We were able to determine the likely cause.The assessment suggests that the rods were not fully reduced when the set screws were advanced done to the rod, causing the torque wrench to signal fixation, despite a gap between the bottom of the tulip and the rod, which could lead to screw loosening.

• Brand Name: THUNDERBOLT MINIMALLY INVASIVE AND LANCER OPEN PEDICLE SCREW SYSTEM
• Common Device Name: THUNDERBOLT/LANCER NEW SET SCREW THREAD
• 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 37922 ; 8652433967
• MDR Report Key: 17787368
• Report Number: 3005819474-2023-00008
• Device Sequence Number: 6454570
• Product Code: KWP
• UDI-Device Identifier: 00840996187404
• UDI-Public: 00840996187404
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K171456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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: MT20-0002
• Device Lot Number: 9550-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 54 YR
• Patient Sex: Male