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

Model Number MT10-7540

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/10/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 335081648
• Report Number: 3005819474-2024-00001
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00840996110495
• UDI-Public: 00840996110495
• 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: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/10/2024
• 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 Age: 58 YR
• Patient Sex: Male