LANCER/ THUNDERBOLT Pedicle Screw System MT20-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840996187404), received between Sep 21, 2023 and Apr 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Migration” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE ROD CAME OUT FROM THE SET SCREW. AS SEEN IN THE IMAGES. THE SCREWS WERE LOOSE AS WELL. THIS IS WHY WE REPLACED THE SCREWS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19031280 ↗
• MalfunctionDec 15, 2023Migration; Migration

  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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18334392 ↗
• MalfunctionDec 15, 2023Migration; Migration

  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 SOME OF THE LEVELS. THIS CAN BE SEEN IN THE IMAGES BELOW PRIOR TO THE REVISION SURGERY. 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. THE ORIGINAL SURGERY INFORMATION WAS: ORIGINAL SURGERY DATE: ON (B)(6) 2023 T12-L1, L1-2, L2-3, L3-4, L4-5 DLIF, L5-S1 ALIF, T12-S1 PSF THE REVISION WAS COMPLETED ON (B)(6) 2023 T12-S1 PSF REVISION, R/T SET SCREWS POPPED OUT. EACH LEVEL SCREW AND SET SCREW IS LABELED IN THEIR OWN CUP. RODS ALSO LABELED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18334375 ↗
• MalfunctionSep 21, 2023Migration; Migration

  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.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17787368 ↗