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

Model Number	MT20-0001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) relayed that 1 of his patients ((b)(6)) experienced postoperative rod/setscrew/pedicle screw interface issues twice.The issues consisted of rods either partially slipping out of or becoming disassociated with the tulips of pedicle screws, postoperatively.After the initial posterior decompression and pedicle screw stabilization from t10 to the pelvis procedure (dos: (b)(6) 2022), the patient returned for a follow-up postoperative visit.X-ray images revealed that the rods had slipped out of the pelvic screw tulips.To address this issue, dr.(b)(6) revised the patient on (b)(6) 2022.The revision case consisted of adding 2 pelvic screws, 2 domino rod-to-rod connectors, 2 cobalt chrome rods (to create a 4-rod stabilization construct), and replacing all the set screws.The patient returned for a postoperative follow-up visit at which time dr.(b)(6) discovered, through x-ray images, that at least 2 of the rods had slipped out of at least 2 of the pelvis screw tulips.
Additional Manufacturer Narrative
The investigation of set screws that backed out on the 2 cases primarily utilized visual observations from follow-up images.These observations indicate that the rod might have been too short at its distal end, which could have hindered the correct attachment of the set screw tulip construct.Another possible factor might be an incorrect set screw lock due to the torque wrench measuring the desired force in pounds before the set screw was fully engaged at the proper tulip position.Unfortunately, based on the available information, a conclusive root cause cannot be established.

• Brand Name: THUNDERBOLT MINIMALLY INVASIVE LANCER OPEN PEDICLE SCREW SYSTEM
• Common Device Name: LANCER,THUNDERBOLT,SET 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: 17816186
• Report Number: 3005819474-2023-00009
• Device Sequence Number: 2480821
• Product Code: KWP
• UDI-Device Identifier: 00840996110891
• UDI-Public: 00840996110891
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: MT20-0001
• Device Lot Number: 8516-70
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/26/2023
• 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: 75 YR
• Patient Sex: Male