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

Model Number MT20-0002

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

Dr.(b)(6) performed a thunderbolt revision on a patient on (b)(6 2023.He removed the original pedicle screws as there was believed to be set screw disengagement on the patient's right side.Can be seen in the images below.Dr.(b)(6) and his distributor returned the screws and associated hardware to choicespine for investigation and analysis.The hardware was provided to the engineering team for investigation in conjunction with quality department.This patient has undergone multiple surgeries as is listed on the image below of a note on the hardware received from the distributor.

Manufacturer Narrative

Images were obtained for all pedicel screws, set screws, and rods associated with the complaint, which found asymmetric depressions or deformation from the rod on the edges of the tulip slot where the rod would rest for the l2 left, l2 right, l3 left, and l4 left constructs, while the l3, right, l4 right, l5 right, l5 left, and s1 left constructs had minimal to no deformation of the tulip slot.S1 right had significant symmetric deformation of the tulip slot.The right constructs experienced less wear, which is reasonable as the l3 right construct was the only set screw that was noted as being tight.This is further justified as there were multiple wear patterns present on the pedicle screw cores and set screws for the l2 left, l2 right, l4 left, l5 left constructs, while the l3 left and l3 right constructs had symmetric rod.However, the l4 right and l5 right constructs had no rod deformation or scarring present on either the cores or the set screws, which would indicate that the rod was not fully reduced in situ.Investigation of the torque required to back out of unlock the new set screws (mt20-0002) versus the old set screws (mt20-0001) was performed with off the shelf production implants (mt11-654-120, mt10-6550, mt20-0001, mt20-0002, mt20-p090, and mt20-p095) at a locking torque of 70 in/lbs.Results of the testing indicated that the unlocking torque for the new set screws was greater than that of the old set screws (43.20 in/lbs.& 33.67 in/lbs., respectively).The unlocking torque of the new set screw is lower than that of the old set screw if there is a gap present between the rod and the tulip (14.90 in/lbs.& 17.90 in/lbs., respectively); however, only n=1 was performed and the difference between unlocking torque is not significant (3 in/lbs.).The part numbers and lot numbers were evaluated for each device returned, which yielded no correlation between manufacturing dates or manufactures.A definite root cause can't be determined at this time; however, due to the uneven wear patterns noted on the left constructs and the lack of wear or deformation found on the l4 right and l5 right constructs.

• Brand Name: THUNDERBOLT MINIMALLY INVASIVE AND LANCER OPEN PEDICLE SCREW SYSTEM
• Type of Device: LANCER,THUNDERBOLT,SET SCREW,NEW 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 37919 ; 8652433967
• MDR Report Key: 18334392
• MDR Text Key: 330594985
• Report Number: 3005819474-2023-00011
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00840996187404
• UDI-Public: 00840996187404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MT20-0002
• Device Lot Number: 9942-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male