MAUDE Adverse Event Report: CHOICESPINE, LLC THUNDERBOLT¿ MINIMALLY INVASIVE AND LANCER¿ OPEN PEDICLE SCREW SYS; THUNDERBOLT,SCREW,POLYAXIAL,7.5X40

Model Number	MT10-7540
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the returned device did not find any indications of wear on the bottom surface or sidewalls of the tulip to indicate that the rod was not properly reduced and contributing to the failure.There have been no other complaints regarding this specific manufacturing batch or lot of pedicle screws and only six total complaints for pedicle screw breakage.As revision surgery was performed to replace the interbody cage after fifteen months of implantation and beach marks or striations were found on the neck of the polyaxial screw, the pedicle screw breakage was likely due to fatigue failure as a result of non-union.
Event or Problem Description
On (b)(6) 2024 pt was taken to surgery for cage removal and psf revision.Original surgery (b)(6) 2022.A tiger shark l was placed today after old cage was removed.During the psf revision, one of the screws was noted to be broken (tulip head was broken from screw shaft) at level s1.

• Brand Name: THUNDERBOLT¿ MINIMALLY INVASIVE AND LANCER¿ OPEN PEDICLE SCREW SYS
• Common Device Name: THUNDERBOLT,SCREW,POLYAXIAL,7.5X40
• 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: 18597671
• Report Number: 3005819474-2024-00001
• Device Sequence Number: 6660658
• Product Code: KWP
• UDI-Device Identifier: 00840996110495
• UDI-Public: 00840996110495
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MT10-7540
• Device Lot Number: 8711-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/29/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male